Überblick über die Statistik des Gehaltsniveaus für "Research Investigator in Deutschland"

Speculative application  Skills: Acne, Actinic Keratosis, Acute Myelogenous Leukemia (AML), AIDS, Allergic Rhinitis, Allergy, Alzheimer's, Anaesthetics, Antibiotics, Anti-infectives, Anxiety, arrhythmia, Asthma, Autoimmune diseases, Autoimmune Disorder, Bacterial Vaginosis, Breast Cancer, Cardiology, Cardiovascular, chemotherapy, Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukemia, Chronic Obstructive Pulmonary Disease, Clinical Pathology, CLL, Congestive Heart Failure, COPD, Cosmetics, Cystic Fibrosis, Dementia, Dentistry, Depression, Dermatology, Diabetes, Diagnostics, Dietetics, Endocrine, Endocrinology, Epilepsy, Family Medicine, Fibromyalgia, Gastroenterology, gastrointestinal, Genetic Diseases, GI, Glioblastoma Multiforme (GBM), Gynaecologic, Gynaecology, Gynecology, Haematology, Haemophilia, Heart Disease, Hematology, Hemopure Anemia, Hepatitis, Hepatology, HIV, Hodgkin's disease, Hypertension, IBD, Immunogenicity, Immunopharmacology, Infections, Infectious Diseases, Influenza, Internal Medicine, Joint Replacement, Lymphoma, Mantle Cell Lymphoma, Melanoma, Menopause, Metabolic, Migraine, Multiple Sclerosis, Musculoskeletal, Myelodysplastic Syndrome, Neonatology, Nephrology, Neurodegenerative disorders, Neurology, Neuroscience, NEUROSURGERY, non small cell lung cancer, Non-Hodgkin Lymphoma, nutraceuticals, Nutrition, OA, Obstetrics, Oncology, Ophthalmology, Oral Health, Orphan Diseases, Orphan drug, Orthobiologic Bone graft, Orthopedic Surgery, Orthopedics, Osteoarthritis, Otitis Externa, Otolaryngology, Ovarian Cancer, Paediatric, Pain, Painful Diabetic Neuropathy, Parkinson’s Disease, Physiology, Podiatry, Post-Menopausal Osteoporosis, Primary Immune Deficiency, Primary Sjogren’s Syndrome, Prostate cancer, Prostatic hyperplasia, Psychiatry, Psychology, Pulmonary, Pulmonology, RA, Rare Disease, Respiratory, retinopathy, Rheumatoid Arthritis, Rheumatology, Rhinitis, Rosacea, Schizophrenia, Seasonal Allergic Rhinitis, Severe Hemophilia, Skin Melanoma, Sleep Disorder, Sleep Medicine, Small Lymphocytic Lymphoma, Small Molecule, Smoking Cessation, Solid Tumors, surgery, Systemic Lupus Erythematosus, Systemic Sclerosis, Tissue Ablation, Transplant, Trauma, Traumatology, Type 2 Diabetes Mellitus, Urology, Vaccine, Vaccines, Vascular Diseases, Weight Loss, Women’s Health, Administrative Assistant, Agile Project Manager, Artwork Coordinator, Associate Director Clinical Operations, Associate Project Manager, Auditor, Biomedical Engineer, Biometrics Manager, Biosample Operations Manager, Biostatistician, Biostatistics Associate Director, Brand Team Lead, Business Administration Associate, Business Administration Manager, Business Analyst, Business Development Associate, Business Development Director, Business Development Manager, CEO, Change Manager, Chemical Project Manager, Chemist, Chemistry, Manufacturing & Control Lead (CMC), Chief Financial Officer, Chief Operating Officer, Chief Technical Officer, Clinical Data Associate, Clinical Data Manager, Clinical Data Specialist, Clinical Development Manager, Clinical Engineer, Clinical Lead, Clinical Operations Director, Clinical Operations Manager, Clinical Pharmacologist, Clinical Programmer, Clinical Project Manager, Clinical Research Associate, Clinical Research Director, Clinical Research Manager, Clinical Research Physician, Clinical Research Specialist, Clinical Study Coordinator, Clinical Study Manager, Clinical Supply Coordinator, Clinical Supply Manager, Clinical Trial Assistant, Clinical Trial Educator, Clinical Trial Manager, Clinical Trial Specialist, CMC Manager, Commercial Manager, Communication Manager, Compliance Associate, Compliance Manager, Computer System Validation Specialist, Contract Associate, Contracts Manager, Country Manager, Customer Service Associate, Data Analyst, Data Analytics Assistant, Data Engineer, Data Management Associate Director, Data Management, Manager, Database Programmer_Designer, Demand Planner, Demand Manager, Developer, Diagnostic Specialist, Director of Contracts & Licensing, Dispensary Assistant, Document Specialist, Drug Safety Associate, Drug Safety Director, Drug Safety Manager, Early Access Project Manager, EHS associate, Electronic Data Capture Manager, Electrophysiologist, Employer Engagement Manager, Engineer (out of industry), Epidemiologist, Exploratory Project Manager, Feasibility Manager, Freelance, FSP Clinical Manager, Global Clinical Data Manager, Graduate, Head of Clinical Data Management, Head of Clinical Operations, Head of Risk Management, Health Economist, Health Information Associate, Healthcare Compliance Manager, HR Associate, HR Manager, Imaging Operations Lead, Inhouse Clinical Research Associate, Intern, Investigator, IT Project Manager, Junior Clinical Data Manager, Junior Clinical Research Associate, Junior Pharmacovigilance officer, Junior SAS Programmer, KOL, Laboratory Assistant, Laboratory Manager, Legal Advisor, Licensing Coordinator, Logistics Associate, Logistics Manager, Logistics Supervisor, Manufacturing Manager, Manuscript Editor, Market Access Manager, Market Access Specialist, Market Insights Specialist, Market Research Associate, Marketing Associate, Material Coordinator, Medical Advisor, Medical Assistant, Medical Devices Project Manager, Medical Director, Medical Information Assistant, Medical Information Associate, Medical Information Manager, Medical Manager, Medical Monitor, medical publisher, Medical Representative, Medical Research Associate, Medical Reviewer, Medical Science Liaison, Medical Technologist, Medical Writer, Medico-economic affairs, Meeting Coordinator, MHRA Pharmacovigilance Inspector, Microbiologist, Occupational Therapist, Office Manager, Ophthalmologist, Packaging Associate, Packaging Coordinator, Patient Recruitment Coordinator, Payroll Specialist, Pharmaceutical Physician, Pharmacist, Pharmacokineticist, Pharmacology Director, Pharmacovigilance Manager, Pharmacovigilance Officer, Physiotherapist, Planning analyst, Policy Officer, Post Doctoral Researcher, Preclinical Project Manager, Principal Biostatistician, Principal Scientist, Privacy Officer, Product manager, Production Manager, Production Specialist, Program Development Manager, Programmer Analyst, Programming Associate Director, Project Assistant, Project Manager (other industry), Proposal Developer, Psychiatrist, Psychologist, Publications Manager, QPPV, Qualified Person, Quality Assurance Assistant, Quality Assurance Complaint Specialist, Quality Assurance Director, Quality Assurance Manager, Quality Assurance Specialist, Quality Control Associate, Quality Control Manager, Quality Control Specialist, Quality Engineer, Quality Manager, Quality Specialist, R&D Manager, R&D Project Manager, Record Specialist, Recruitment & Screening Co-ordinator, Registration Specialist, Regulatory Affairs Administrator, Regulatory Affairs Associate, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs VP, Regulatory Documentation Scientist, Regulatory Information Specialist, Regulatory labelling specialist, Regulatory Program Manager, Regulatory Site Activation Manager, Remote Site Monitor, Senior, Research Coordinator, Research Funding Manager, Research Team Manager, Resources Manager, Respiratory Physiotherapist, Sales Manager, Sales Rep, Sample Manager, SAS Programmer, Scientific Advisor, Scientific Affairs Associate, Scientist, Senior Associate Supply Chain (GMP), Senior Biostatistician, Senior Clinical Lead, Senior Clinical Research Associate, Senior Clinical Supply Chain Associate, Senior Clinical Team Manager, Senior Clinical Trial Manager, Senior Epidemiologist, Senior Medical Affairs Officer, Senior Nutrition Scientist, Senior Regulatory Affairs Manager, Senior Scientist, Site Engagement Manager, Site Visit Report Reviewer, SOFTWARE DEVELOPER, Software Engineer, Start Up Director, Start-up Manager, Start-Up Specialist, Strategy Lead, Study Authorisation Associate, Study Delivery Operational Specialist, Submissions Manager, Supply Chain Coordinator, Supply Chain Manager, Supply Chain Planner, Surgical Technician, Systems Administrator, Technical Project Leader, Technical Services Specialist, Training Associate, Training Manager, Translator, Validation Engineer, Vendor Manager, Veterinary Nurse, Warehouse Associate, Warehousing & Distribution Leader, BSc, CQA, GMC, MBA, MBChB, MD, MPhil, MRCPsych, MSc, No CRA Certificate, PGDip, Ph.D Statistics, Pharm D, PhD, PRINCE2, Registered Nurse, SAP, Six Sigma, SolTRAQs, Veterinary, 3PL, ADaM, Administration, Adverse Event management, Advocacy plans, Agile, AKTA, Analytical SEC, Animal Health, APICS, Applicant Tracking System Management, APS, ARISg, auditing, Batch release, Batch Review, BHV, Bioequivalence, Bioinformatics, Biologic, Biomarkers, biometrics, Biosamples, Biosimilars, Biostatistics, Biotech, Black Belt, Business Development, C++, Candidate Attraction, CAPA, CDISC, Cell Biology, Cell stem-based therapy, CER, Chemstations, Client communication, Clinical, Clinical Affairs, Clinical Data Management, Clinical Programming, Clinical Research Organisation, Clinical Trial Applications, clinical trials, close out visits, CMC, CMO, Commercialisation, Compassionate Use, Competent Authorities, Computer Systems Validation, Contract, CPIM, CRF Design, CRO, CSR, Data Analysis, data entry, Data Science, Data Warehouse, database design, Datalabs, DHPC, Distribution, Distribution Planning, DMC, Document Management, Downstream, Drug destruction, Drug Development, Drug Safety, DSUR, E2E, Early Access, Early Phase, EC Submissions, ECG, eCRF, EDC, electronic data capture, ELISA, Epidemiology, ePRO, ERP, eTMF, e-TMF, EU Legislation, Eudravigilance, European Federation of Pharmaceutical Industries, Export Management, FDA Audits, Feasibility, Finance, Forecast, FPLC, GCP, GDP, Gene Therapy, Global, Global Regulatory Affairs, GLP, GMP, Government Affairs, GS1 standards, Health Economics, Healthcare, Healthcare Compliance, Healthy Volunteers, Home-based, HPLC, IATA, ICF, ICH-GCP, Imaging, Immunology, IMP, IMPACT, IMPD, Import Management, IND, InForm, Informatics, International, Interviewing, Inventory Management, Investigator Payments, in-vitro, in-vivo, IRB Submissions, IRT, ISO 13485, ISO 13485:2003, ISO 14971, ISO 9001, ISO13485, IVRS, Java, Lab, Labelling, Laboratory, LEAN, Line Management, Logistics, MA-CC, Manufacturing, MAPP, Market Access, Market Insights, Market Intelligence, Market Research, Marketing, Marketing authorizations, Materiovigilance, MedDRA, Medical Affairs, Medical Communication, Medical Devices, Medical Information, Medical Writing, Medidata Rave, Monitoring, Monitoring Visit, MS Office, MS Project, My Trials, NMR, Office-based, Oracle, Outcomes Research, Outsourcing, Packaging, Paediatrics, Patient Outcomes, Permanent, PET scans, Pharma, Pharmaceutical, Pharmacodynamics, Pharmacoeconomics, Pharmacoepidemiology, Pharmacokinetic, Pharmacokinetics, Pharmacology, Pharmacovigilance, Pharmacy, Phase I, pipetting, PMP, Policy, Post Marketing, Postdoctoral research, Post-marketing, Preclinical, Pricing & Reimbursement, Pricing and Reimbursement, PROC, Process Excellence, Procurement, Product Management, Project Leadership, Project Management, PromoMats, Protein Characterisation, protocol development, Protocol writing, PSURs, Public Affairs, publishing, Purchasing, QP, Qualification Visit, Quality Assurance, Quality Control, Quality Management, Quality Management System, Radiology, Randomisation, Randomization, Rave, Reactovigilance, Real World Evidence, Recruitment, Regional Monitoring, Regulatory, Regulatory Operations, Regulatory submissions, Regulatory Systems Management, remote monitoring, RFI, Risk Management, risk-based monitoring, RMA, RMP, SAE, SAE reporting, Sales Inventory, Sample size estimation, Samples, SAS, Scrum, SDS-PAGE, SDTM, Serialisation, Shipments, shipping, Simoa, Site contracts, Site Engagement, site payments, SOX, SPC- CCDS, Spectroscopy, S-Plus, SPSS, SQL, Start-up activities, statistical analysis, Statistics, Study Management, Study Medication Labelling, Sunshine Act, Supplier Qualification, Supply Chain Distribution, Supply Chain Management, Supply Chain Planning, Supply Planning, SUSAR, SUSARs, TMF, Toxicogenomics, Toxicology, Trackwise, Training, Transport Management, Unicorn Purification System, UPLC, Upstream, UV-Vis Spectroscopy, validation, Veeva, Vendor Management, Venipuncture, VISIO, Western Blot, ZINC, Bratislava, Slovakia, Afrikaans, Argentinian, Armenian, Belgian, Bosnian, Bulgarian, Cambodia, Cantonese, Catalonian, Chinese, Croatian, Czech, Danish, Dutch, English, Flemish, French, Greek, Gujarati, Hebrew, Hungarian, Italian, Japanese, Korean, Latvian, Lithuanian, Luxembourgish, Macedonian, Malayalam, Mandarin, Montenegrin, Norwegian, Persian, Punjabi, Romanian, Russian, Serbian, Slovak, Slovene, Slovenian, Spanish, Swedish, Thai, Turkish, UkrainianLocation: GloballyShare: 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Location: Poland- Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Germany- Home based        Schedule: Freelance, Various FTEs                                  CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Germany. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home based          Schedule: Freelance, Various FTEs                                      CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager II, to join their clinical operations team in Spain. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                                    Join our team and help us deliver clinical trials that will improve patients' lives.            Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project-specific trainingOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process     Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.            If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.          Who will you be working for?          About CROMSOURCE        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos     Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.          CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.          Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Germany- Home based        Schedule: Freelance, Various FTEs                                     CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Senior Clinical Project Manager,  You will be working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies.       As a Senior Clinical Project Manager, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.                         Join our team and help us deliver clinical trials that will improve patients' lives.        Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projectsManage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team membersKeep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedKnowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areasAssure the proper timelines of the assigned projectsManage the budget for the projectMonitor the workload and the performance of the project teamPlan and monitor the tasks of the team in the specific areasCoordinate the Clinical Research Associates and Clinical Monitors activityCollaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activitiesAssist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDelivering  project specific trainingsOrganise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetingsProvide project updates to the Sponsor, Senior Project Manager,  and Project Director/Leader as requiredInform the Project Director/Leader about any issuesPerform co-monitoring visits for the assigned clinical projects as necessaryAct as a tutor for Project Coordinators and Project Managers IMaintain relationships with the Sponsor, including providing project updatesPrepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying with and enforcing Company procedures Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similarExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation                         Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, Project Management, Study ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Italy - home based      Schedule: Full-time, Permanent             CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II/SCRA).  You will manage clinical projects to ensure quality, budget, and timelines are met while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. The studies you will initially be assigned to will be within Oncology, Respiratory, Medical Devices, and Cardiology.                 Join our team and help us deliver clinical trials that will improve patients' lives.               Main Job Tasks and Responsibilities:Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedAssists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.May act as Feasibility Associate after appropriate and documented training.Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the siteCooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.Will be the main contact person for the site in order to ensure close follow up.Provides general support to the Clinical Research Division on quality control of clinical data.Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial.Develops training material and gives training in collaboration with the Training & Qualification Management UnitMay assist in contract negotiation with sites on study budget after appropriate and documented training.Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job. Education and Experience:University Degree in scientific medical or paramedical disciplinesPrevious proven experience as a CRA, performing on-site monitoring activitiesStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements Specific Role Requirements and Skills:Fluent in EnglishProficiency in Microsoft Office (e.g. Word, Excel, Outlook)Willingness to travel The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. The Application Process      Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step. If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact mailto:[email protected] for more information.             Who will you be working for?             About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                            Our Company Ethos      Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.       CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.             Keywords: Clinical Research Associate, CRA, Site Management, Monitor, Monitoring, Oncology, Respiratory, Medical Device, Cardiology, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent, Pharma, Outsourcing.Skills: Cardiology, Oncology, Respiratory, Clinical Research Associate, clinical trials, CRO, Medical Devices, Monitoring, PharmaLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Poland - Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager I, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.   Join our team and help us deliver clinical trials that will improve patients' lives.                   Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team memberOversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical stateManages the budget of the projectParticipates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the SponsorSupervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulationsUndertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levelsMay provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activitiesSupervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projectsMay act as Feasibility Associate (FEA) after appropriate and documented trainingMay prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them Education and Experience:University Degree in scientific, medical, or paramedical disciplinesUp to three 3 years of project management experience in the CRO/Pharmaceutical industryStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Poland - home-basedSchedule: Freelance - 0.5 FTE Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research Associate to join one of our sponsors in Poland. This sponsor is focused on developing innovative immuno-oncology and precision medicines. CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.   Main Job Tasks and Responsibilities: Verify safety and well-being of study subjects are maintained for assigned study sites.Support the operational execution of clinical trials and ensure the collection of high-quality, substantiated data.Execute clinical trial activities following established standard operating procedures, good clinical practices, and regulatory requirements.Accountable for study site performance and providing high-quality data according to overall project timeline.Assist Clinical Operations staff and study site staff in quickly and effectively resolving issues.Respond to problems and assist in implementing corrective and preventive actions, if required.Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.Responsible for supporting patient recruitment and retention activities.Performs site visits and ensures the study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies, and procedures.Assists with internal communication of important clinical data and events.Support the organization of Investigators and other study training meetings, if required.Functions as a reliable, trusted resource for accurate, up-to-date study site status knowledge, as requested by key stakeholders.Understand the business value of clinical projects and balance overall business objectives and functional needs.May be involved in other tasks to support Clinical Operations and Operating Company as needed.Support the implementation of new clinical systems/processes.Interface and collaborate with Investigators contractors/vendors, and company personnel as needed.May be asked to provide additional support to Clinical Operations staff, as needed. Education and Experience:A Bachelor's Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.At least 3 years of relevant experience.Previous immune-oncology experience, early phase trial experience monitoring, or equivalent experience required.Relevant industry certifications preferred.Experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and PowerPoint).English Written and verbal communications.Presentation and influencing.Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).Ability to travel up to 80% of the time.Full driving license. The Application ProcessOnce you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact [email protected] for more information. Who will you be working for? About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                About TalentSource Life Sciences TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Contract Research Assistance, CRA, Freelance, FL, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Research Associate, Freelance, Clinical Research Organisation, clinical trials, CRO, OutsourcingLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - home-basedSchedule: Freelance - 1.00 FTE Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research Associate to join one of our sponsors in Spain. This sponsor is focused on developing innovative immuno-oncology and precision medicines. CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.   Main Job Tasks and Responsibilities: Verify safety and well-being of study subjects are maintained for assigned study sites.Support the operational execution of clinical trials and ensure the collection of high-quality, substantiated data.Execute clinical trial activities following established standard operating procedures, good clinical practices, and regulatory requirements.Accountable for study site performance and providing high-quality data according to overall project timeline.Assist Clinical Operations staff and study site staff in quickly and effectively resolving issues.Respond to problems and assist in implementing corrective and preventive actions, if required.Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.Responsible for supporting patient recruitment and retention activities.Performs site visits and ensures the study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies, and procedures.Assists with internal communication of important clinical data and events.Support the organization of Investigators and other study training meetings, if required.Functions as a reliable, trusted resource for accurate, up-to-date study site status knowledge, as requested by key stakeholders.Understand the business value of clinical projects and balance overall business objectives and functional needs.May be involved in other tasks to support Clinical Operations and Operating Company as needed.Support the implementation of new clinical systems/processes.Interface and collaborate with Investigators contractors/vendors, and company personnel as needed.May be asked to provide additional support to Clinical Operations staff, as needed. Education and Experience:A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.At least 3 years of relevant experience.Previous immune-oncology experience, early phase trial experience monitoring, or equivalent experience required.Relevant industry certifications preferred.Experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and PowerPoint).English Written and verbal communication.Presentation and influencing.Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).Ability to travel up to 80% of the time.Full driving license. The Application ProcessOnce you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact [email protected] for more information. Who will you be working for? About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                About TalentSource Life Sciences TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Contract Research Assistance, CRA, Freelance, FL, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Research Associate, Freelance, Clinical Research Organisation, clinical trials, CRO, OutsourcingLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Italy - Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Italy. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                               Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Italy:· Meal vouchers· Mobile phone if requested by the Line Manager· Dedicated Line Manager Who will you be working for?                                    About CROMSOURCE                       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                    Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                        CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home-based          Schedule: Permanent, Full-time                         Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Spain. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                  As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.                   Join our team and help us deliver clinical trials that will improve patients' lives.                                         Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel  The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per yearDedicated Line Manager Who will you be working for?                                             About CROMSOURCE                            CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                              Our Company Ethos                       Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                             The Application Process                       Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.                       If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                                  CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                             Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, Senior Clinical Trial Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Belgium - Home based    Schedule: Permanent, Full-time                           Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their internal team in Belgium. This role is a full-time permanent opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                  As a Senior Clinical Project Manager, you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.                             Main Tasks and Responsibilities:Manage and coordinate the assigned clinical projects.Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.Knowledgeable in the application process for clinical studies, in force in the country/ies of work.Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.Assure the proper timelines of the assigned projects.Manage the budget for the project.Monitor the workload and the performance of the project team.Plan and monitor the tasks of the team in the specific areas.Coordinate the Clinical Research Associates and Clinical Monitors activity.Collaborate with he Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activitiesCollaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Collaborate with the CTAs in archiving activities.Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study ReportsDeliver project specific trainings.Organise and participate in Monitor and Investigator MeetingsOrganise or take part in the periodic project update meetings.Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.Inform the Project Director/Leader about any issues.Perform co-monitoring visits for the assigned clinical projects as necessary.Act as a tutor for Project Coordinators and Project Manager IMaintain relationships with the Sponsor, including providing project updates.Prepare the SOPs relating to clinical research activities in collaboration with the Quality System UnitCollaborate in complying and enforcing Company procedures. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplinesProven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similar.Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursement The Application Process           Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.                        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please send an mail to: [email protected] for more information.                     Who will you be working for?                                            About CROMSOURCE                           CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus on the heart of everything we do.                                                            Our Company Ethos                      Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.                                                         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                             Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research OrganisationSkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Germany- Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Germany. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                                 Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company.25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. Who will you be working for?                                    About CROMSOURCE                        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                      Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                          CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Trial Manager, clinical trials, CRO, Medical Devices, Project Leadership, Project ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Gemeinsam Großes bewegen – mit einer Karriere, die Dich inspiriert Gemeinsam Großes bewegen – mit einer Karriere, in der Du mehr erreichen kannst Herzlich willkommen bei Abbvie! Als Teil eines internationalen Unternehmens mit über 48.000 Mitarbeitern weltweit und rund 3.000 Mitarbeitern in Deutschland hast Du die Möglichkeit, eng mit uns zusammenzuarbeiten, um die gesundheitlichen Herausforderungen von morgen zu meistern. Du hast eine Leidenschaft für die Verbesserung der Gesundheitsversorgung auf der ganzen Welt? Du möchtest Dein Fachwissen einsetzen, um die Lebensqualität von Patienten zu verbessern? In einem herausfordernden Arbeitsumfeld, das Dir die Möglichkeit bietet, Deine eigenen Fähigkeiten zu erweitern und zu entwickeln? Dann bist Du bei uns richtig! In unserem Research und Development Bereich am Standort Ludwigshafen arbeitest Du in einem Team von talentierten Mitarbeitern*innen und erfahrenen Experten*innen an den Produkten von Morgen. Mit herausragenden Technologien sorgst Du im Labor für die höchsten Standards im Wettbewerb. Gemeinsam großes bewegen – als Senior Assay Development Specialist (Scientist II / Senior Scientist I)Setze ein Zeichen: Entwicklung und Validierung von bioanalytischen Methoden, insbesondere zellbasierte Methoden und Ligandenbindungsassays, zur quantitativen Analytik und Immunogenität von Biologika (therapeutische Antikörper, Antibody-Drug Conjugates und Antikörper-basierte Fusionsproteine) sowie von Zell- und Gentherapien im Rahmen von toxikokinetischen und klinischen Prüfungen gemäß gängiger internationaler Guidelines (z.B. FDA, EMA, ICH, OECD)Erweiterung des bestehenden Methodenrepertoires, einschließlich Evaluierung neuer Technologien, z.B. im Rahmen von Zell- und GentherapienTroubleshooting, wissenschaftliche und Erarbeitung von LösungsstrategienKoordination der Analyse von toxikokinetischen und klinischen Prüfungen in der Rolle des Principal Investigators/Principal Bioanalytical InvestigatorsGewährleistung der Grundsätze der Guten Laborpraxis (GLP) sowie der Good Clinical Practice (GCP)Erstellung und Pflege einer GLP/GCP- bzw. richtlinienkonformen Dokumentation (z.B. SOPs, Prüfpläne, Berichte)Kommunikation und Diskussion der erarbeiteten Ergebnisse, auch bereichsübergreifend, in internationalen ProjektteamsVerfolgung des internen und externen wissenschaftlichen Umfelds und Umsetzung der für AbbVie wichtigen Neuerungen und Erkenntnisse in die tägliche ArbeitQualifikationen:Scientist II: Bachelor oder gleichwertiger Abschluss und 7 Jahre Berufserfahrung oder Master oder gleichwertiger Abschluss und 5 Jahre Berufserfahrung in Pharmazie/Biotechnologie/Chemie/Physik/Verfahrenstechnik oder verwandter Bereiche. Die Berufsausbildung kann durch gleichwertige Kenntnisse ersetzt werden, die durch Berufserfahrung als Associate Scientist/Scientist erworben wurdenSenior Scientist I: Bachelor- oder gleichwertiger Abschluss und 10 Jahre Berufserfahrung, Master- oder gleichwertiger Abschluss und 8 Jahre Berufserfahrung in Pharmazie/Biotechnologie/Chemie/Physik/Verfahrenstechnik, Promotion mit erster BerufserfahrungFundierte Kenntnisse zellbasierter Methoden, (insbesondere Flow Cytometry)Erfahrung in der Entwicklung, Validierung und Etablierung von komplexen bioanalytischen Methoden für BiologikaProteinbiochemische und bioanalytische KenntnisseErfahrung mit der Automatisierung bioanalytischer Methoden wünschenswertFähigkeit zum kritischen Hinterfragen bestehender Methoden bzw. Vorgaben und Ausarbeitung eigener LösungsansätzeFähigkeit, sich selbst und die Arbeitsabläufe im Labor effizient zu organisierenSehr gute englische Sprachkenntnisse in Wort und SchriftGute Kenntnisse bioanalytisch relevanter Regularien (FDA, EMA, ICH, OECD) und Erfahrung in der Arbeit gemäß GxP-QualitätsstandardsSehr gute EDV-KenntnisseBasiswissen ArbeitssicherheitWie wir gemeinsam Großes bewegen: mit einem diversen Arbeitsumfeld, wo Du etwas bewirken kannstmit einer offenen Unternehmenskulturmit einer attraktiven Vergütungmit einem intensiven Onboarding inkl. einem Mentor *inmit flexiblen Arbeitsmodellen für eine gesunde Work-Life-Balancemit einem betrieblichen Gesundheitsmanagement mit umfassenden Gesundheits- und Bewegungsprogrammenmit betrieblichen Sozialleistungenmit vielfältigen Karrieremöglichkeiten in einer internationalen Organisationmit hochkarätigen, attraktiven Entwicklungsmöglichkeitenmit einem starken, internationalen Netzwerk Wir wurden mehrfach und weltweit zum „Great Place to Work“ gewählt und sind stolz darauf, unseren Mitarbeitern*innen die Flexibilität zu bieten, die eine gesunde Work-Life-Balance gewährleistet. Wir nehmen unseren Einfluss auf die Umwelt und die Gesellschaft ernst und konzentrieren und deshalb darauf, regelmäßig etwas zurückzugeben. Wir engagieren uns für Gerechtigkeit, Gleichheit, Vielfalt und Inklusion (EED&I) – das ist von grundlegender Bedeutung für uns. Dazu gehört die Wertschätzung unterschiedlicher Perspektiven, die Schaffung einer integrativen Kultur und der würdevolle und respektvolle Umgang mit allen Mitarbeitern*innen.Bei AbbVie zählt Dein individueller Beitrag – Hilf uns, gemeinsam Großes zu bewegen. Sei ein Teil von unserem Erfolg und wachse mit uns – und wachse über Dich hinaus! Klingt wie die perfekte Karrierechance für Dich? Dann freuen wir uns auf Deine Bewerbung. Alles, was Du benötigst, ist ein vollständiger Lebenslauf – alles Weitere besprechen wir dann persönlich mit Dir. Hast Du noch Fragen? Schicke uns gerne eine E-Mail an ********** – wir freuen uns auf Deine Kontaktaufnahme!AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.Über das Unternehmen:ABBVIE

JOB SUMMARY: Clinician Services Engagement Associate works in a pivotal role of managing communication and activities among clinical research sites, and internal stakeholders to prepare for and complete clinical assessments in accordance to the project specific scope of work. The successful incumbent provides quality customer service and assures that activities related to assessments are performed and delivered on time and according to client expectations. EDUCATION REQUIREMENTS: Bachelor’s Degree in health care, life sciences or related field or equivalent work experience in pharmaceutical/ biotechnology industry. QUALIFICATIONS/EXPERIENCE: At least 2 years of previous clinical research trial or related experience. Experience working directly with sponsors and sites with a proven record of successfully managing clinical assessments related projects preferred. Experience working with psychiatric (e.g. depression, anxiety) indications is a plus. Must possess basic knowledge of the clinical trial process, GCPs, FDA, regulations, and related clinical terminology. Knowledge of IRB regulations is a plus. Proficient in using office management software with the ability to manage databases, generate reports, and analyze data. Experience with an eCOA platform is a plus. Technical skills and ability to troubleshoot hardware, software, and network issues. Ability to work independently and cross functionally in a fast-paced environment and support multiple projects concurrently. Excellent organizational, prioritization and time management skills. Excellent communication, and problem-solving skills. ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Partner with external customers such as clinical research sites, and internal customers such as clinical science, and clinician services to successfully deliver the services as outlined in the scope of work related to clinical assessments. Ensure the Company standards and expectations in the Clinician Services are met and adhered to as measured by visit availability, wait times, clinician utilization, and safety reporting compliance. Manage multiple clinical trials simultaneously while ensuring that assessments are scheduled, initiated, and completed following the study protocol requirements and design. Provide study administrative support such as data entry, report generation, and database management. Develop and maintain positive relationships with study participants, healthcare professionals, and other stakeholders. Provide basic technical support for hardware, software, and network issues to sites, as needed. May develop project specific manuals for the Assessment Solutions team as outlined in the study scope of work to ensure contracted services are clearly outlined as required. Independently investigate, resolves, and/or escalates issues to the appropriate internal team members. Assist with the onboarding of new clinical research sites by helping with tasks such as site training, testing of equipment, and mock assessments. Monitor query notification and resolution process with sites to ensure and protect data integrity. Monitor reports to track subject visits and ensure compliance with risk reporting processes. Review protocols to support custom report generation for monitoring and tracking of data captured in the clinical eCOA system. Develop and implement new strategies to mitigate any risk that could lead to study protocol deviation. Monitoring for the alerting of Investigators/Sites, Clients and the Clinical Science team and designated personnel when a patient risk has been reported and ensuring that the risk has been acknowledged by both the Investigator/Site and Client. May assist with the development of site facing IR documents as well as internal project plans specific to the Assessment Solutions services provided as detailed in the project scope of work. Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here. Attendance and punctuality are essential functions of the position. TRAVEL REQUIREMENTS: Up to 5% based on business needs. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM. #LI-Remote Standort WCG Clinical, Munich

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.We are looking for a Senior Clinical Research Associate to join our team in GermanyThe Sr CRA will be responsible for the following tasks: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting. Collects and reviews regulatory documents as required. Prepares site visit reports and telephone contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment. Acts as the main line of communication between the project team and the site staff. Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight. Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution. Ensures the continuous maintenance of the Trial Master File and Investigator Site File. Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission. Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts. Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings. May translate, coordinate translations or review completed translations of the essential documents as required. May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department. Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income. Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings. Provides secondary in-house review of CRFs (if required). Support site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. May be assigned other tasks / activities / responsibilities related to the study execution in the country. May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality. Must work both independently and in a team environment. Requirements At least three years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / health care / nursing background and/or related degree. Sound knowledge of medical terminology and clinical monitoring process. Strong communication in Local and English language in both written and verbal skills. Strong interpersonal and organizational skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations Representative, outgoing and client focused Ability to work in a fast-paced challenging environment of a growing company In-depth therapeutic and protocol knowledge Ability to perform travel an average of 65%, depending on project needs. In-depth therapeutic and protocol knowledge as provided in previous, or company provided training. Attention to detail. Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients. Demonstrated ability to manage multiple projects. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues. Ability to manage multiple projects Benefits Comprehensive benefits package Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for fully remote working or hybrid Working Model Leadership and mentoring opportunities Internal growth opportunities and career progression More task variety Financially rewarding internal Employee Referral Program Access to online soft-skills and technical training via GoodHabitz and internal platforms To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes#LI-BL1 Standort Allucent, Munich

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary: Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders. Position Responsibilities: Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s Assessment and set up the of vendors during study start up period (locally) Investigator Meeting participation and preparation Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel Validation of study related materials (i.e. protocol, ICF, patient material) Responsible for preparing country specific documents (e.g. global country specific amendment) Prepares materials for Site Initiation Visits Responsible for verifying and confirming with local team eTMF completeness (Country and Site level) Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Lead study team meetings locally Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable) Management of Site relationships (includes CRO related issues) May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs) May perform site closure activities, including post-close out May act as point of contact for Sites May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances. Depending on the experience and previous knowledge of the specific candidate, the position may be adjusted to the Senior Level. Senior Level Expectations: Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Position Requirements: Degree Requirements: Bachelors or Masters degree required. Field of study within life sciences or equivalent Experience Requirements: Clinical Trial Manager: Minimum of 4 years' industry related experience Senior Clinical Trial Manager: At least 6 years of industry related experience Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Key Competency Requirements: Thorough understanding of GCP, ICH Guidelines and Country regulatory environment In depth knowledge and understanding of clinical research processes, regulations and methodology Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Demonstrated organizational and planning skills and independent decision-making ability Strong organization and time management skills and ability to effectively manage multiple competing priorities Ability of critical thinking and risk analysis. Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels Skilled in the use of technology Good verbal and written communication skills (both in English and local language). Software that must be used independently and without assistance (e.g., Microsoft Suite): Microsoft Suite Clinical Trial Management Systems (CTMS) Electronic Data Capture Systems (eDC) Electronic Trial Master File (eTMF) Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs. This fixed-term role is meant as maternity cover until 30.06.2025. #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **********. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:0044 BMS GmbH&Co.KGaA Germany

Location: Baden-Württemberg Germany - Site-basedSchedule: Freelance - 0.5 FTE   Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds…   The sponsor-dedicated division of ClinChoice, is searching for a Clinical Study Nurse to join one of our clients.   ClinChoice is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.     Main Job Tasks and Responsibilities: Assists project teams with study-specific documentation as appropriate.Completion of Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs).Tracking and Quality Control, maintaining drug accountability records, completion of site status reports.Ensures that review source documents e.g. laboratory reports are reviewed and signed by The Investigator.Understand ICH GCP, relevant regulations, and site SOPs.The maintenance of the study files and the databases for the project.Co-coordinates ordering/dispatch and tracking of trial materials.Assists project teams with trial progress tracking and updating distribution tasks by updating the Clinical Trial Management systems.Supports for tracking and safety reporting of study progress.Provides activity reports expenses and timesheets to the Company.Reporting of adverse events (AEs) serious adverse events (SAEs) to all relevant personnel parties.Entering data into the eCRF.Working with the Clinical Research Associate (CRA) to resolve queries.Adhering to the site and study-specific protocol training whilst undertaking visit duties.Maintaining standards of professional competence and current clinical practices under ICG_GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements.Completing study visits at the site in line with the study protocol requirements.Provision of excellent standards of service provision following study protocol training and country-specific requirement.Adhering to the Sponsor/Site training and study-specific protocol training, whilst undertaking visit duties.Ensures that all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate.Working at site and Patient Services team and Country Lead to ensure that all aspects of service for assigned groups of subjects are met, through the adherence to study schedules, protocols, and local clinical practice regulations and requirements.Flexible approach to working hours to accommodate the dynamic nature of research visits. Education and Experience:Registered Nurse or Medical Assistant with at least 2 years of post-registration experiencePrevious experience as a Research Nurse or Medical Assistant including a recent (within the last 1 year) ICH-GCP update.Experience in neurology is desirable. Skills Requirement:Measurement of vital signs (i.e., blood pressure, pulse rate, BMI, etc.).Performing ECG.Drawing of blood.Performing the infusion including putting on the infusion tubes and clinical monitoring during/after infusion (following training).Ship blood/laboratory samples to the central lab (training and instructions will be provided).Check questionnaires.Report AEs/SAEs.Liaise with the study team.Enter visit data into eCRF.Database screening.Discuss study information with subjects to aid informed consent.Coordinates all participant visits including inviting study participants, coordinating the visits with the pharmacy, the neuroimaging unit, the local lab, and the home health.Coordinates accounting for travel expenses of study participantsAssists the Principal Investigator (PI) in determining subject eligibility.SAE reporting through safety gateway.Make eCRF entries/corrections/resolve DCFs…Selection and randomisation procedures using IRS.Communicate with IEC.Maintain documentation in the Investigator Site File.Infusion experience essential.Good phlebotomy skills.ECG recording.Managing infusion reactions.Demonstrated organisational skills.Proven flexibility and the ability to work under pressure.Good communication skills.Proficiency in German mandatory, English desirable.Proactive contribution towards the team by being a flexible team player.Ability to work effectively both in a team & independently in a fast-paced environment.Excellent understanding of the clinical processes.Good knowledge of clinical trials, including EU Clinical Trials Directives, Good Clinical Practice for Clinical Trials, and German regulations is desirable, training can be provided.Excellent computer skills required, MS Office proficiency at a minimum. The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @  https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information.     Who will you be working for?     About ClinChoice       CROMSOURCE is now a ClinChoice Company. ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to the pharmaceutical, biotechnology, medical device and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinCHoice has established major delivery centres across US, Canada, China, Europe, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.        Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     Keywords:  Study Nurse, Research Nurse, Trial Nurse, MS Office, German, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Nurse, Registered Nurse, Clinical Research Organisation, clinical trials, CRO, MS Office, Pharma, PharmaceuticalLocation: GermanyShare: LinkedIn Facebook Twitter Email

GSK’s portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally. Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people. GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA. In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation. General medicines include our inhaled medicines for asthma and COPD, antibiotics, and medicines for skin diseases. By 2031, we aim to deliver more than £33 billion in annual sales – a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world. And we’re confident in our future. Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients. Medical Science Liaison - Hematology (m/f/d) Medical Affairs is a critical bridge between R&D and the commercial organization to ensure that our medicines reaches the appropriate patients. The MSL Manager is a critical role to ensure oncology resource and activities are aligned and deployed to business priorities and patient needs. The function is crucial to build up scientific expertise to provide greater insight and significant external presence. Region: Baden-Württemberg Key Responsibilities This role will provide you the opportunity to lead key activities as follows: Creating and forming measures and programs out of the medical strategy within their designated scope, schedule, and resources Management of all medical affairs activities in the territory Development, implementation and project lead of medical scientific projects Identification and support of relevant study centres and cooperation partners and intensification of scientific dialogues (discussion of latest publications, data and therapies; scientific presentation and moderation of advisory boards / symposiums; …) Acting as a partner of choice and consultant for all external KOL´s and HCP´s Support of clinical research programming across the continuum (Investigator sponsored research, Cooperative Group and Collaborator research, Company Sponsored trials) Partnering within all areas of GMA (e.g. Medical Directors, Medical Communications, Medical Information, Publications, Patient Advocacy) and support as content expert for Clinical Research, Sales, Marketing, Market Access, Patient Advocacy, Communications Qualifications & Skills We are looking for professionals with these required skills to achieve our goals: Accredited doctorate degree in a life-science or basic-science discipline (Pharm.D., D.Sc., D.N.P., Ph.D., or M.D./D.O.) Clear evidence of Oncology experience - preferably within last few years Demonstrated understanding of the European healthcare environment, including knowledge of health technology assessments and market access challenges as well as understanding of Pharmaceutical ethics and governance, of pharmaceutical compliance policies and procedures Expert public speaking and written communication skills Successful and superior influencing skills across all levels of the organization and with external collaborators Problem solving and risk-mitigation skills Fluency in English and German Willingness to travel extensively Preferred Qualifications & Skills If you have the following characteristics, it would be a plus: Demonstrable experience and success in MSL organizations in therapeutic oncology Prior experience with product launches Financial and budget management Find out more: Annual Report 2022 Product Pipeline #EBDE Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.Über das Unternehmen:582 GlaxoSmithKline GmbH & Co. KG

Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.As a Clinical Research Associate (level depends on experience) you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner.TasksWhat You’ll DoServe as main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with or oversee study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings; may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project TeamRequirementsWhat You Bringminimum 2-3 years clinical research experience as a CRA or related profession in Germany - without the experience an applications doesn't make any senseLife science backgroundExcellent knowledge in ICH-GCP and regulatory requirementExperience in Transplant and AKI or oncologyFluent in spoken and written language in German and in EnglishBenefitsWhy CTI?At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.For that reason, we treat our team members with the respect they deserve, and our numbers show it:We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forwardWe value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training departmentWe value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home scheduleOur culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industryWe think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROsOur work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to marketAfter an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.Are you interested? Then we look forward to your electronic application, with a tabular CV in English, as well as information about your earliest possible starting date and your salary expectation!CTI Clinical Trial and Consulting Services Europe GmbHFrau Samy WeiseSchillerstrasse 1/15 | 89077 Ulm, GermanyFrom a small team in an old carriage house to associates in more than 60 countries across the world. Standort CTi Clinical Trials & Consulting Service GmbH, Ulm