Data Management Expert for Clinical Research

1 dag geleden

Utrecht, Utrecht, Nederland NLwerkt Voltijd

NLwerkt is seeking a Data Management Expert to join our Human Evidence and Insights Generation department. We are an International Food Innovation Company situated in Utrecht, the Netherlands.

We offer a competitive salary of around €65,000 - €85,000 per annum, depending on experience.

Job Description

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. 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.

Main Responsibilities
  • Oversight of all data management activities
  • Setting up contracts with eCRF vendors
  • Designing (electronic) case report forms (CRFs) including programming of edit checks and validation of the database
  • Writing User Acceptance Testing (UAT) plans, Data Validation Plan (DVP) and Data Management Plans (DMP)
  • Performing User Acceptance Testing (UAT)
  • Performing query management and data validation
  • Performing medical coding in collaboration with the Medical Monitor
  • Performing Serious Adverse Event (SAE) reconciliation in cooperation with the safety team
  • Performing Lab Sample reconciliation
  • SDTM mapping of clinical data
  • Preparing Centralized Data Monitoring (CDM) and Periodic Medical Review (PMR) Meetings
  • Preparing the safety review meeting
  • Preparing the Data Review Meeting (DRM)
  • Performing the database lock
  • Monitoring study timelines and identifying risks
  • Being the Data Management expert in multidisciplinary study teams

You will work closely with stakeholders in Research & Innovation science teams, providing data solutions to scientific studies. This is an excellent opportunity to collaborate with international experts and contribute to the development of innovative solutions for the food industry.

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