Senior Clinical Data Manager

4 weken geleden

Utrecht, Utrecht, Nederland Danone Voltijd

About the Role

We are seeking a highly skilled Senior Clinical Data Manager to join our team at Danone. 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.

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 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 for data management activities.

About You

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 the pharmaceutical, nutritional, or academic research industry. 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, as well as an interest in new tools and processes, and a willingness to learn.

About Us

Danone is a global company committed to creating a healthier world. We offer a competitive primary salary and yearly bonus, as well as benefits like a premium free pension, 30 days annual leave, and several discounts on collective health insurance and our products. We also offer a hybrid working environment, which enables each team to meet our people's desire for flexibility.

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