Clinical Data Manager
2 maanden geleden
Job Title: Clinical Data Manager - Data Governance Specialist
Company: Yacht Life Sciences
Location: Utrecht, Netherlands
Job Type: Full-time
About the Role:
We are seeking a highly skilled Clinical Data Manager to join our Human Evidence Data Operations team at Yacht Life Sciences. 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:
- Data Governance: Ensure that all data management activities are in compliance with regulatory requirements and company policies.
- Data Quality: Design and implement data validation plans to ensure the accuracy and integrity of clinical data.
- Data Management: Set up contracts with eCRF vendors, design electronic case report forms (CRFs), and perform user acceptance testing (UAT).
- Query Management: Perform query management and data validation to ensure that all data is accurate and complete.
- Medical Coding: Perform medical coding in collaboration with the Medical Monitor.
- Serious Adverse Event (SAE) Reconciliation: Perform SAE reconciliation in cooperation with the safety team.
- Lab Sample Reconciliation: Perform lab sample reconciliation.
- SDTM Mapping: Perform SDTM mapping of clinical data.
- Meetings and Reporting: Prepare centralized data monitoring (CDM) and periodic medical review (PMR) meetings, as well as data review meetings (DRM).
- Database Lock: Perform the database lock.
- Study Timelines and Risks: Monitor study timelines and identify risks.
- Collaboration: Actively collaborate with and provide support to multidisciplinary study teams.
Requirements:
- Strong understanding of clinical data management principles and regulatory requirements.
- Excellent communication and collaboration skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
- Proficiency in data management software and tools.
What We Offer:
At Yacht Life Sciences, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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