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Clinical Data Manager

2 maanden geleden


Utrecht, Utrecht, Nederland Yacht Voltijd
Join Yacht Life Sciences as a Clinical Data Manager

We are seeking a highly skilled Clinical Data Manager to join our Human Evidence Data Operations team at an International Food Innovation Company in Utrecht, the Netherlands.

About the Role

As a Clinical Data Manager, you will be responsible for setting up and maintaining data collection tools according to the Protocol, and for following the entire data management process until the database lock.

Key Responsibilities
  • Oversight of all data management activities
  • Setting up contracts with eCRF vendors
  • Design and programming of electronic case report forms (CRFs)
  • Development of User Acceptance Testing (UAT) plans, Data Validation Plan (DVP), and Data Management Plans (DMP)
  • Performing User Acceptance Testing (UAT)
  • Query management and data validation
  • Medical coding in collaboration with the Medical Monitor
  • Serious Adverse Event (SAE) reconciliation in cooperation with the safety team
  • Lab Sample reconciliation
  • SDTM mapping of clinical data
  • Preparation of Centralized Data Monitoring (CDM) and Periodic Medical Review (PMR) Meetings
  • Preparation of the safety review meeting
  • Preparation of the Data Review Meeting (DRM)
  • Database lock
  • Monitoring study timelines and identifying risks
  • Providing data management expertise in multidisciplinary study teams
Requirements

We are looking for a highly skilled and experienced Clinical Data Manager who can provide the best solutions and processes for data management in clinical research.

What We Offer

As a Clinical Data Manager at Yacht Life Sciences, you will have the opportunity to contribute to the development of nutritional solutions that bring clinically proven health benefits to vulnerable consumers.