Senior Clinical Data Manager
Danone
- Utrecht
- Vast
- Voltijds
- Design & validate electronic data capture instruments (eg. electronic case report) including automated data entry checks and validation of the database outputs
- Lead and support innovation projects in the field of clinical data
- Act as a mentor for junior associates in the team
- Writing/ validation of the user acceptance testing (UAT) plan, Data Validation Plan (DVP) and Data Management Plan (DMP)
- Perform User Acceptance Testing (UAT)
- Perform query management and data validation
- SDTM mapping of clinical data
- Prepare the safety review, perform medical coding and Safety Adverse Events (SAE) reconciliation in cooperation with the Medical Monitor
- Prepare the Data Review Meeting (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
- Master's degree in Biomedical or Life Sciences
- Minimum of 5 years of experience in clinical data management in pharmaceutical, nutritional or academic research
- Knowledge of CDISC (CDASH and SDTM)
- Demonstrated ability to take initiative and work independently
- Has an interest in new tools and processes, willing to learn
- Experience with Electronic Data Capture (EDC), MedDRA, WHO Drug
- Programming experience (SAS/R/Python)
- Fluent in English (speaking and writing)
- A 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
- all applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.