Senior Clinical Data Team Lead
vor 2 Wochen
The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.Summary of Key ResponsibilitiesContribute to data management activities as a lead study data manager in support of Client's clinical studiesLead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testingMonitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviewsOversight of database lock activities and ultimate archiving of study dataCollaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendorsEstablish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviewsReview CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentationContribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulationRepresent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendorsParticipate in the training of external vendors and site staffParticipate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are metReview clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.Support GCP inspection readinessQualificationsBS/BA in scientific discipline,At least 7 years related experience in a pharmaceutical/biologics/biotechnology companyExperience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferredExpert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management SystemsKnowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASHExperience working with Medidata RaveExperience using standardized medical terminology, including MedDRA and WHODrugExperience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS ProjectExcellent written and oral communications skillsHighly motivated and flexible, with excellent organizational and time management skillsAbility to work independently and as part of a multi-disciplinary teamUnderstanding of ICH GCP as well as general knowledge of industry practices and standardsKnowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11NDA/MAA experienceIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
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Data Team Lead/Senior Data Team Lead
Vor 6 Tagen
Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit 80.000 € - 120.000 € pro JahrJOIN US ON OUR EXCITING JOURNEYIQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity...
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Clinical Program Lead
vor 2 Wochen
Frankfurt Am Main, Deutschland BI International GmbH Vollzeit**THE POSITION**: As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the indication area Gastroenterology/Crohn’s Disease from start of development through to registration. This may include definition of Target Product Profiles, design and execution of...
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(Senior) Clinical Program Leader Oncology
vor 2 Wochen
Frankfurt am Main, Deutschland Haybury VollzeitMy client is a leading pharmaceutical company, who are looking for a Global Clinical Lead to join their team and drive the development of Oncology assets **As Global Clinical Lead you will**: - Contribute to Global Clinical Strategy - Author Clinical Development Plans, Clinical Protocols, TPP and design Clinical Studies - Interpret Clinical Data, with...
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Associate Director Clinical Data Management
vor 1 Woche
Frankfurt am Main, Deutschland Proclinical VollzeitProclinical are recruiting an Associate Director Clinical Data Management - Germany for a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. *** **Responsibilities**: - Serve as a mentor for the new starters or possibly assign to suitable team members this action. - Offer constant feedback...
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(Senior) Clinical Program Leader
vor 2 Wochen
Frankfurt Am Main, Deutschland BI International GmbH Vollzeit**Tasks & Responsibilities**: - In your new role, you are responsible for the design and preparation of late clinical development plans in the TA CardioMetabolism & Respiratory (CMR), and submission documents to prepare assets in one or more of the following areas: Obesity, Non-Alcoholic Steatohepatitis (NASH), Cardiovascular indications, and/or chronic...
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Clinical Operations Lead
Vor 6 Tagen
Frankfurt am Main, Deutschland Alimentiv Vollzeit**JOB TITLE**:Clinical Operations Lead **LOCATION**:Netherlands, Canada, US, Germany, UK or Romania (Home-based) **REPORTS TO**: Manager, Monitoring & Site Management (Europe & Asia Pacific) **DEPARTMENT/UNIT NAME**: Monitoring & Site Management **JOB SUMMARY**: Responsible for the clinical operations of a project within a defined regional/global level....
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Clinical Trial Lead
vor 1 Woche
Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit 70.100 € - 100.000 € pro JahrThe IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with early phase clinical research projects (phase I and II) in different therapeutic areas. As...
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Clinical Trial Lead
Vor 4 Tagen
Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit 70.100 € pro JahrThe IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with early phase clinical research projects (phase I and II) in different therapeutic areas. As...
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Senior Advisor Clinical Research
vor 2 Wochen
Frankfurt Am Main, Deutschland Eli Lilly VollzeitAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
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Senior Clinical Research Associate
vor 2 Wochen
Frankfurt, Deutschland AL Solutions VollzeitSenior Clinical Research Associate – Germany (Home-Based, French Speaking)Chloe O’Shea is pleased to be working with a small global CRO recognised for driving innovation and excellence in clinical development. We are seeking an experienced Clinical Research Associate to join a sponsor-dedicated team, home-based in Germany. This is a unique opportunity to...
