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Senior Clinical Data Manager
2 maanden geleden
Senior Clinical Data Manager
We are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international study team, you will be responsible for overseeing the clinical data management process in clinical trials.
Key Responsibilities- Design and validate electronic data capture instruments, including ePRO and eCRFs.
- Work with Medical Device and App vendors to set up data collection and oversee data transfer and cleaning.
- Create automated data entry checks and validation of database outputs.
- Lead and support innovation projects in clinical data management.
- Act as a mentor for junior associates.
- Develop and implement data management plans, including UAT, DVP, and DMP.
- Perform query management and data validation.
- Apply industry-standard data models, including CDISC CDASH and SDTM.
- Prepare safety reviews, perform medical coding, and reconcile SAEs with the Medical Monitor.
- Prepare Data Review Meetings and database lock.
- Monitor timelines and risks.
- Collaborate with preclinical and life science researchers.
- Oversight of CROs performing data management activities.
We are looking for a Senior Clinical Data Manager with a strong background in digital health and clinical data management. The ideal candidate will have:
- A Master's degree in Biomedical or Life Sciences.
- Minimum 5 years of experience in clinical data management in pharmaceutical, nutritional, or academic research.
- Experience working with data from electronic Patient Reported Outcome and/or Medical Devices.
- Knowledge of CDISC (CDASH and SDTM).
- Demonstrated ability to take initiative and work independently.
- Interest in new tools and processes, willing to learn.
- Programming experience (SAS/R/Python).
- Fluent in English (speaking and writing).
- Solid understanding of biomedical research, clinical trials, and Good Clinical Practice (GCP).
At Danone, we offer a dynamic and inclusive work environment that values innovation and entrepreneurship. We are committed to creating a healthier world and are proud to be a B-Corp certified company. We offer a competitive salary, yearly bonus, premium free pension, 30 days annual leave, and discounts on collective health insurance and our products.
We are an equal employer and welcome applications from all qualified candidates. To comply with GDPR regulations, we require consent to process your personal data. Please apply directly via our website.
