Clinical Data Manager
2 maanden geleden
Yacht Life Sciences has an opportunity for aClinical Data Manager at an International Food Innovation Company situated in Utrecht, the Netherlands.
As a Clinical Data Manager, you will be a member of the Human Evidence Data Operations team, which is part of the Human Evidence and Insights Generation department. As a Clinical Data Manager you are 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.
You will provide the best solutions and processes for data management for clinical research. You will contribute to the development of nutritional solutions that bring clinically proven health benefits to vulnerable consumers - infants, toddlers, expecting mothers, the elderly, and patients.
As a Clinical Data Manager, you are a member of an international multi-disciplinary study team. You are responsible for the data management process in clinical studies and report to the Team Leader Data Management. There is the opportunity to collaborate with stakeholders in Research & Innovation science teams, providing data solutions to scientific studies.
You will perform the following tasks:
- Oversight of all data management activities
- Setting up contracts (requesting cost quotations and work orders) with eCRF vendors
- Design (electronic) case report forms (CRFs) including programming of edit checks and validation of the database
- Write User Acceptance Testing (UAT) plans, Data Validation Plan (DVP) and Data Management Plans (DMP)
- Perform User Acceptance Testing (UAT)
- Perform query management and data validation
- Perform medical coding in collaboration with the Medical Monitor
- Perform Serious Adverse Event (SAE) reconciliation in cooperation with the safety team
- Perform Lab Sample reconciliation
- SDTM mapping of clinical data
- Prepare Centralized Data Monitoring (CDM) and Periodic Medical Review (PMR) Meetings
- Prepare the safety review meeting
- Prepare the Data Review Meeting (DRM)
- Perform the database lock
- Monitor study timelines and identify risks
- Be the Data Management expert in multidisciplinary study teams
- Actively collaborate with and provide support to multidisciplinary study teams.
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