Überblick über die Statistik des Gehaltsniveaus für "Clinical Study Manager in Deutschland"

Location: Belgium - Home and Office based    Schedule: Full Time         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 Project Manager to join a one of our partner companies. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.         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 counter-parts.           Main Job Tasks and Responsibilities:  Initiates and manages all operational study/project activities and serves as primary point of contact for the assigned Core Project teamsTranslates protocol/project strategies from a concept into an executable study/projectFocuses upon the operational integrity and feasibility of individual studies utilizing a variety of resource solutions to ensure the most effective, efficient, and high quality study/project is designed and executedParticipates in and influences the operational strategy for study/project delivery including milestone deliverables to optimize use of time, cost and resourcesParticipates in the identification, assessment and mitigation of risks at the study levelMaintains continuous communication between partner lines, strategic partners, Clinical Research Units (CRU), contractors and vendorsOptimize Operational Control and EffectivenessAssures close partnership with study investigators to assure successful study delivery and high quality dataFosters positive community attitudes and volunteer trust through professional behavior and ongoing communication Education, Experience and Skills:Minimum of BA/BS in a biomedical discipline or equivalent education/training is requiredAt least 5 years relevant experience in clinical research and drug development with clinical operations experiencePreferably with first experience in early drug development (Phase I and IIa)Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issueExperience in Project Management and leadership of matrix teams is essentialFluent in speaking and reading English. Preferably, your second language would be French or DutchDrug development experience including familiarity with: Clinical study management and monitoring, Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technologyInitiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quoMatrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguityEase in using Office tools suite (Excel, Powerpoint, Word, Outlook, etc…)Good organizational skills for seamless interactions with Core Study Teams, Investigators, Regulatory Department and Clinical staff The Benefits of Working in BelgiumCompetitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the functionDedicated Line ManagerRegular face-to-face or phone meetings with line managerFull annual performance review processAd-hoc team 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 acknowledgement that we received it. If you have the requirements we need, you will be invited for 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.                          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 are evidenced by our below industry average turnover rates.         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 the 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 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 Project Manager, Clinical Trial Manager, Clinical Study Manager, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicatedSkills: Clinical Project ManagerLocation: BelgiumShare: 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 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

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Als führendes globales Auftragsforschungsinstitut (CRO) mit einer Leidenschaft für wissenschaftliche Präzision und einer jahrzehntelangen Erfahrung in der klinischen Entwicklung, bietet Fortrea Kunden aus der Pharma-, Biotechnologie- und Medizintechnikbranche ein breites Spektrum an Lösungen für die klinische Entwicklung, den Patientenzugang und die Technologie in mehr als 20 Therapiebereichen. Mit über 19.000 Mitarbeitern, in mehr als 90 Ländern, verändert Fortrea die Arzneimittel- und Medizinprodukteentwicklung für Partner und Patienten auf der ganzen Welt. Als Clinical Project Manager in unserer Abteilung Flexible Solutions sind Sie von zentraler Bedeutung für die erfolgreiche Durchführung komplexer klinischer Studien (Phasen II und III) in Deutschland. Sie arbeiten dabei direkt mit einem der globalen Top 5-Pharmaunternehmen zusammen. Diese Position ermöglicht es Ihnen, an der Entwicklung innovativer Medikamente, die einen neuen Standard insbesondere im Bereich der Onkologie setzen, mitzuwirken, während Sie exklusiv für einen unserer wichtigsten internationalen Kunden tätig sind.Wenn Sie Verantwortung übernehmen, Ihre Führungsqualitäten ausbauen und Ihr umfassendes Know-how in der klinischen Forschung einsetzen möchten, dann ist diese Position eine großartige Gelegenheit. Kommen Sie zu uns und überzeugen Sie sich selbst, warum mehr als 90 % der 20 weltweit führenden Pharmaunternehmen seit vielen Jahren zu unseren Kunden zählen!Was Sie von uns erwarten dürfen:eine bedeutungsvolle Tätigkeit in einem stabilen, diversen, erfolgreichen und angesehenen Unternehmeneine attraktive und konkurrenzfähige Vergütung, einschließlich 13. Gehalt und Urlaubsgeldeine echte Work-Life-Balanceflexible Arbeitszeiten sowie betriebliche Regelungen zum FreizeitausgleichReisezeit = Arbeitszeitein umfassendes Onboarding mit Unterstützung durch Ihren persönlichen Mentoreinen unbefristeten Home-Office-Arbeitsvertrageinen attraktiven, arbeitgeberfinanzierten Pensionsplanhervorragende Fortbildungs- und Entwicklungsmöglichkeiten sowie Unterstützung bei Ihren persönlichen Weiterbildungsplänenkontinuierliche Unterstützung durch Ihren Line Manager, Ihr Team sowie über 20'000 Kolleg*innen weltweitIhre Aufgaben:Verantwortlich für die erfolgreiche Durchführung Ihrer Studien in Deutschland von Feasibility bis StudienabschlussBindeglied zwischen Global Headquarter, Country Operations und den StudienteamsAufbau und Pflege vertrauensvoller, nachhaltiger Beziehungen zu den Prüfärzten, den Studienzentren sowie dem lokalen StudienteamIhr Background:Naturwissenschaftlicher Hochschulabschluss in einem relevanten Fachbereich wie z.B. Biologie, Biochemie, Chemie, Gesundheitswesen, Pharmakologie, Medizin usw.; alternativ eine abgeschlossene Berufsausbildung im Bereich Gesundheit/Pflege oder gleichwertige Berufserfahrung (z. B. als Study Nurse, Research Nurse, Studienkoordinator*in..)Fundierte Berufserfahrung im Projektmanagement klinischer industrie-gesponsorter Studien (Onkologie-Erfahrung wünschenswert)Gute Kenntnis der deutschen Einreichungsprozesse bei Ethikkommissionen und BehördenFührungsqualitäten durch Coaching, Mentoring und/oder Koordination von Teamseffizientes Zeitmanagement und Organisationstalent sowie eine sorgfältige, detailgenaue Arbeitsweiseausgezeichnete Kommunikationsfähigkeiten in verhandlungssicherem Deutsch sowie gute Englischkenntnisse in Wort und Schrift sind ein MussFortrea sucht aktiv nach motivierten, lösungsorientierten und kreativen Denkern, die unsere Leidenschaft für die Überwindung von Hindernissen bei klinischen Studien teilen. Unser Ziel ist es, den Entwicklungsprozess zu revolutionieren und sicherzustellen, dass lebensverändernde Ideen und Therapien schnellstmöglich Patienten zur Verfügung gestellt werden. Werden Sie Teil unseres außergewöhnlichen Teams und profitieren Sie von einem kollaborativen Arbeitsumfeld, in dem Ihre persönliche Entwicklung gefördert wird und Sie einen bedeutenden globalen Einfluss ausüben können. Weitere Informationen über Fortrea finden Sie unter www.fortrea.com.REMOTE#LI-AR1Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.

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 :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

Das sind Ihre neuen Aufgaben Von der Planung bis zur Durchführung und Bewertung betreuen Sie die regulatorischen und wissenschaftlichen Aufgaben zur Erbringung der notwendigen klinischen Nachweise für unsere IVD-ProdukteFür die Entwicklung und Leistung unserer IVD-Produkte ermitteln Sie klinische bzw. diagnostische KriterienSie erarbeiten produktspezifische klinische Bewertungsstrategien inkl. statistischer Elemente bei der Planung klinischer Leistungsstudien, stellen die Einhaltung der Pläne sicher, bewerten Änderungen, werten resultierende Daten entsprechend aus und fassen die Ergebnisse in Berichten für die technische Dokumentation zusammenBei der Durchführung der Leistungsstudien stellen Sie die Einhaltung regulatorischer und ethischer Anforderungen sicherDarüber hinaus sind Sie bei der Weiterentwicklung unserer Prozesse zur klinischen Leistungs bewertung sowie zur Analyseleistung beteiligtFür Ihre Kollegen in anderen Fachbereichen, z.B. Entwicklung und Produktmanagement, sind Sie wichtiger Ansprechpartner für Fragestellungen zu Leistungsdaten und durchgeführten Studien Das zeichnet Sie aus Ihr Masterstudium der Ingenieur- oder Naturwissenschaften wie z. B. Medizintechnik, Biologie oder Biotechnologie haben Sie erfolgreich abgeschlossen und idealerweise um eine Promotion im Fachgebiet Immunologie ergänztSie bringen mehrjährige Berufserfahrung im regulatorischen Bereich eines IVD- oder MDR-Herstellers und der Durchführung von analytischen und klinischen Studien mit; idealerweise können Sie zusätzlich Erfahrung mit dokumentierter Literaturrecherche und Statistik vorweisenMit Ihrem analytischen Denkvermögen und Ihrer strukturierten Arbeitsweise fällt es Ihnen leicht, komplexe Sachverhalte schnell zu erfassen und aufzubereitenIhre sehr guten Deutsch- und Englischkenntnisse wenden Sie bei der Dokumentation und im Austausch mit unseren ausländischen Niederlassungen sicher anDank Ihrer Kommunikationsstärke und einem ausgeprägten Teamgeist können Sie zwischen den Fachabteilungen gut vermitteln und Ihren Kollegen als kompetenter Ansprechpartner stets weiterhelfen Das erwartet Sie Ein sicherer Job für die Zukunft - Unbefristete Arbeitsverträge in einer krisensicheren und zukunftsorientierten BrancheEin gutes Gleichgewicht zwischen Beruf und Freizeit - Flexible Arbeits- und Pausenzeiten rund um die Kernarbeitszeit, Stundenkonto, 30 Urlaubstage, mobiles Arbeiten (nach Absprache möglich)Kollegen, bei denen man sich wohl fühlt - Familiäre Arbeitsatmosphäre, Du-Kultur auf allen Ebenen, Onboarding und Patenprogramm, TeameventsGute Arbeit zahlt sich aus - 13 Gehälter, Mitarbeiterempfehlungsprogramm, übergesetzliche Zuschüsse zu Ihrer AltersvorsorgeGesundheit ist das höchste Gut - Ausgewogene Ernährung im Betriebsrestaurant, Getränkeflatrate, Betriebsarzt, Physioservice und Massagen, diverse FirmensportgruppenViel Abwechslung, auch nach Feierabend - Mitarbeiterveranstaltungen, Kreativ-Workshops, Sonderkonditionen für Veranstaltungen, Rabattaktionen für Produkte und DienstleistungenFeedback, das gehört wird - Jährliche Mitarbeitergespräche, regelmäßige MitarbeiterbefragungenUnd vieles mehr! Standort EUROIMMUN Medizinische Labordiagnostika AG, Lübeck

Stellenbeschreibung: Senior Account Manager - Clinical Study Sites (m/w/d)Position: Senior Account Manager - Clinical Study Sites (m/w/d)Standort: Remote oder hybrid OptionUnternehmensprofil:Ein inhabergeführtes Unternehmen im Bereich der Organisation klinischer Studien mit breitem Angebotsportfolio.Aufgaben und Verantwortlichkeiten:Strategische Planung:Entwickeln Sie eine langfristige Strategie für die klinischen Studienzentren, die die Unternehmensziele unterstützt.Identifizieren Sie potenzielle Standorte und Partnerschaften, um die Präsenz in relevanten geografischen Gebieten zu stärken.Standortauswahl und -management:Verantwortlich für die Auswahl und Bewertung von klinischen Studienzentren.Führen Sie Verhandlungen mit Partnerinstitutionen, um optimale Studienbedingungen sicherzustellen.Teamführung:Bilden und leiten Sie ein Team von Standortmanagern und -koordinatoren.Unterstützen Sie die berufliche Entwicklung und Weiterbildung des Teams.Qualitätsmanagement:Sicherstellen der Einhaltung von regulatorischen Anforderungen und ethischen Standards an allen Studienstandorten.Implementieren Sie Qualitätskontrollprozesse und -maßnahmen.Kommunikation und Zusammenarbeit:Koordinieren Sie die Kommunikation zwischen den Studienstandorten, internen Abteilungen und externen Partnern.Fördern Sie eine effektive Zusammenarbeit und einen Informationsaustausch.Budgetplanung und -verwaltung:Entwickeln und überwachen Sie das Budget für klinische Studienstandorte.Identifizieren Sie Einsparungsmöglichkeiten und optimieren Sie Ressourcenallokationen.Qualifikationen:Abgeschlossenes Hochschulstudium in Medizin, Naturwissenschaften oder einem verwandten Bereich von VorteilDeutschlandweite ReisebereitschaftMehrjährige Erfahrung in der klinischen Forschung, vorzugsweise in einer Führungsposition.Erfahrung in der Kommunikation mit niedergelassenen Ärzten - Vorhandenes Netzwerk von VorteilTiefgreifendes Verständnis der regulatorischen Anforderungen im Bereich klinischer Studien.Nachgewiesene Erfolgsbilanz bei der Kundengewinnung und Kundenbindung (B2B oder B2C)Starke Führungsqualitäten und Erfahrung in der Leitung von interdisziplinären Teams.Ausgezeichnete Kommunikations- und Verhandlungsfähigkeiten.Analytisches Denkvermögen und strategische Ausrichtung.Bitte senden Sie Ihren Lebenslauf und ein Anschreiben an Toni Xayaphone -> E-Mail anzeigen oder bewerben sich direkt über den Link.Ich freue mich auf Ihre Bewerbung! Standort i-Pharm Consulting, Berlin

Stellenbeschreibung: Senior Account Manager - Clinical Study Sites (m/w/d)Position: Senior Account Manager - Clinical Study Sites (m/w/d)Standort: Remote oder hybrid OptionUnternehmensprofil:Ein inhabergeführtes Unternehmen im Bereich der Organisation klinischer Studien mit breitem Angebotsportfolio.Aufgaben und Verantwortlichkeiten:Strategische Planung:Entwickeln Sie eine langfristige Strategie für die klinischen Studienzentren, die die Unternehmensziele unterstützt.Identifizieren Sie potenzielle Standorte und Partnerschaften, um die Präsenz in relevanten geografischen Gebieten zu stärken.Standortauswahl und -management:Verantwortlich für die Auswahl und Bewertung von klinischen Studienzentren.Führen Sie Verhandlungen mit Partnerinstitutionen, um optimale Studienbedingungen sicherzustellen.Teamführung:Bilden und leiten Sie ein Team von Standortmanagern und -koordinatoren.Unterstützen Sie die berufliche Entwicklung und Weiterbildung des Teams.Qualitätsmanagement:Sicherstellen der Einhaltung von regulatorischen Anforderungen und ethischen Standards an allen Studienstandorten.Implementieren Sie Qualitätskontrollprozesse und -maßnahmen.Kommunikation und Zusammenarbeit:Koordinieren Sie die Kommunikation zwischen den Studienstandorten, internen Abteilungen und externen Partnern.Fördern Sie eine effektive Zusammenarbeit und einen Informationsaustausch.Budgetplanung und -verwaltung:Entwickeln und überwachen Sie das Budget für klinische Studienstandorte.Identifizieren Sie Einsparungsmöglichkeiten und optimieren Sie Ressourcenallokationen.Qualifikationen:Abgeschlossenes Hochschulstudium in Medizin, Naturwissenschaften oder einem verwandten Bereich von VorteilDeutschlandweite ReisebereitschaftMehrjährige Erfahrung in der klinischen Forschung, vorzugsweise in einer Führungsposition.Erfahrung in der Kommunikation mit niedergelassenen Ärzten - Vorhandenes Netzwerk von VorteilTiefgreifendes Verständnis der regulatorischen Anforderungen im Bereich klinischer Studien.Nachgewiesene Erfolgsbilanz bei der Kundengewinnung und Kundenbindung (B2B oder B2C)Starke Führungsqualitäten und Erfahrung in der Leitung von interdisziplinären Teams.Ausgezeichnete Kommunikations- und Verhandlungsfähigkeiten.Analytisches Denkvermögen und strategische Ausrichtung.Bitte senden Sie Ihren Lebenslauf und ein Anschreiben an Toni Xayaphone -> E-Mail anzeigen oder bewerben sich direkt über den Link.Ich freue mich auf Ihre Bewerbung! Standort i-Pharm Consulting, Munich

Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated