Senior Clinical Data Manager
2 weken geleden
About the Role
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 be responsible for overseeing the clinical data management process in clinical trials, with a focus on digital health data.
Key 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 lock.
- 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.
About You
We are looking for a Senior Clinical Data Manager with a strong background in digital health data management, who possesses the following skills and competencies:
- Master's degree in Biomedical or Life Sciences.
- Minimum of 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.
- MedDRA, WHO Drug.
- Programming experience (SAS/R/Python).
- Fluent in English (speaking and writing).
- Solid understanding of biomedical research, clinical trials, and Good Clinical Practice (GCP), drug/product development.
- Pragmatic attitude and being adaptable to the changing needs of the business, being agile and flexible.
About Us
At Danone, we offer a complete package of benefits, with a competitive primary salary and yearly bonus, but also benefits like a premium free pension, 30 days annual leave, and several discounts on a collective health insurance and even on some of our products. In the Netherlands, we also offer a hybrid working environment, which enables each team to meet our people's desire for flexibility. Across our 3 office hubs in Hoofddorp, Zoetermeer, and Utrecht, this helps us create better opportunities for connection and synergies across our entities, teams, functions, and categories.
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