Überblick über die Statistik des Gehaltsniveaus für "Clinical Trial Associate 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: Denmark - Home-Based & Site visits  Schedule: Part-time; 0.25 FTE; Freelancer      CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture. We are recruiting a dynamic person to join our in-house team as a Freelance Clinical Research Associate, based in Denmark. You will be working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. This role has one active site in Aarhus, Denmark. Experience with acute or chronic liver failure trials is preferred. Nephrology experience would be ideal. Work from home and at the site, 0.25 FTE.       Join our team and help us deliver clinical trials that will improve patients' lives.        Main Job Tasks and Responsibilities:Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure a good start-up of the investigation sites.Performs training of site staff in all study procedures to ensure protocol/ICHGCP compliance.Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of Case Report Form (CRF) in compliance with the protocol, SOPs, and ICH-GCP requirements in order to ensure data integrity and subject safety.Adapts and translates Patient Information Leaflets and Informed Consent FormsCooperates with the site staff for ensuring proper reporting from the site of the safety issues (adverse events and adverse reactions such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.Escalates any issues to relevant project team members.May assist in contract negotiation with sites on the study budget after appropriate and documented training.May support the submission process in the project (or region) Education and Experience:You have a University Degree in scientific medical or paramedical disciplines.Prior experience as a CRA, including submissions and contract negotiation experience.Excellent knowledge of clinical trial operations, ICH-GCP Guidelines, and other applicable regulatory requirementsFluent in EnglishProficiency 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 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 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 assets. 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 instruments 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: CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, Submissions, Clinical Research, ICH-GCP, Monitoring, Home based, Monitoring visits, Freelance, Freelancer, Contractor.Skills: Clinical Research Associate, Freelance, Clinical Research Organisation, clinical trials, CRO, Home-based, ICH-GCP, MonitoringLocation: DenmarkShare: LinkedIn Facebook Twitter Email

Location: Europe - home-basedSchedule: 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.  We are recruiting for a dynamic person to join our in-house team as a Director of Business Development - PV, MA & RA Services. You will be responsible for lead generation, opportunity assessment, creating new accounts, and growing existing accounts. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Identify, assess, and pursue new business opportunities.Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.Work to exceed revenue targets that align with the company's growth objectives. Education and Experience:6+ years of sales and account management experienceExperience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory AffairsEstablished a network of decision-makers in the life-sciences industry.Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.Strong negotiation skills with a proven track record of closing complex business dealsPersuasive and compelling presentation and communication skills, both written and verbalAbility to interpret business challenges and present quick and responsive high-level solutions.Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.Positive employer and client referencesBA, MBA, or equivalent experience The Application ProcessOnce 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 EthosOur 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 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: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account managementSkills: Business Development Director, Business Development Manager, Clinical Research Associate, Business Development, clinical trials, CROLocation: EuropeShare: 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: Netherlands - 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 Netherlands. 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 Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation daysInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager 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 @

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

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

Job Summary :Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in the DACH region, specifically in Munich, Germany. Clinical Trial Managers with expertise in CNS and Neuroscience are welcome to continue to work in their area of expertise or to expand to a new therapeutic area. We provide remote flexibility after probation to the DACH region only with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.Responsibilities :Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic area, and indicationProvide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is providedReview and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicableDevelop operational project plansManage risk assessment and executionResponsible for management of study vendorManage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverablesQualifications :Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;Experience in Phases 1-4; Phases 2-3 preferred;Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;Management of overall project timeline;Bid defense experience preferred; andStrong leadership skills.Medpace Overview :Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.Why Medpace? :People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace PerksHybrid work-from-home options (dependent upon position and level)Competitive PTO packagesCompany-sponsored employee appreciation events Employee health and wellness initiativesFlexible work scheduleCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthAwardsRecognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Über das Unternehmen:Medpace, Inc.

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