TMF Quality and Process Compliance Manager

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11762en
  1. Contract
  2. English
  3. Associate
  4. Research & Development
  5. Basel
  6. Healthcare & Life Sciences
  7. TMF, Monitoring, Clinical Research, Clinical Development, GCP
This vacancy has now expired
For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role as a TMF Quality and Process Compliance Manager. This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment. It is a contract position for 1 year.

Your mission:
- Monitoring of TMF process compliance using metrics, while ensuring optimal functioning of TMF processes and systems
- Developing KPIs/KQIs to measure quality and completeness of TMFs
- Tracking progress to KPIs/KQIs, and overall compliance to TMF processes
- Identifying and escalating trends/metrics to CDGM representatives to develop remedial actions
- Supporting compliance and overview of mandatory TMF training
- Tracking recent TMF audit and inspection findings to ensure proper oversight by CDGM across the compnay's portfolio.

Your profile:
- Bachelor’s degree in life science/healthcare
- 3-5 years of experience in global clinical research/clinical operations
- Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice
- Excellent understanding of system data structures and Clinical Document Management System functionality
- Excellent communication, organization and tracking skills
- Fluency in English


If you believe you have the right skill set and would like to be considered for the role, please apply directly or send your CV to vasil.mihaylov@swisslinx.com

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