Senior Clinical Data Manager
4 weken geleden
We are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international, multi-disciplinary study team, you will play a central role in managing data from electronic Patient Reported Outcome (ePRO) and/or medical devices.
Responsibilities- Design and validate electronic data capture instruments, including ePRO/eCOA and eCRFs.
- Collaborate with Medical Device and App vendors to set up data collection for various digital tools and oversee the data transfer and cleaning process.
- 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 in the team.
- Develop and implement user acceptance testing (UAT) plans, data validation plans (DVP), and data management plans (DMP).
- Perform UAT and query management, as well as data validation.
- Apply industry-standard data models, including CDISC CDASH and SDTM.
- Prepare safety reviews, perform medical coding, and reconcile Safety Adverse Events (SAE) with the Medical Monitor.
- Prepare Data Review Meetings (DRM) and database locks.
- Monitor timelines and risks.
- Collaborate with and provide support to (pre)clinical and life science researchers.
- Oversight of CROs performing data management activities.
- Setting up contracts with new CROs to perform data management activities.
We are looking for a Senior Clinical Data Manager with a Master's degree in Biomedical or Life Sciences, and a minimum of 5 years of experience in clinical data management in pharmaceutical, nutritional, or academic research. You should have experience working with data from electronic Patient Reported Outcome and/or Medical Devices, and knowledge of CDISC (CDASH and SDTM). You should also have a demonstrated ability to take initiative and work independently, and be willing to learn new tools and processes.
About UsWe are Danone, a B-Corp certified company that meets the highest verified standards of social and environmental performance, transparency, and accountability. We offer a complete package of benefits, including a competitive primary salary and yearly bonus, premium free pension, 30 days annual leave, and several discounts on collective health insurance and our products. We are proud to be an equal employer and foster an inclusive working culture that is accessible for all.
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