Description
TMF Manager Outsourced Studies for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
* Thorough knowledge of clinical Trial Master File process, regulatory requirements and GCP, in particular for outsourced TMF filing activities
* At least 5 years in clinical development/clinical operations
* At least 3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
* Advanced knowledge of clinical documentation and reporting
Your tasks:
- Support the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
- Oversee the process, system and tool landscape that supports the management of outsourced TMFs.
- Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice:
- Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.
Start: ASAP
Duration: 24MM+
Location: Basel, Switzerland
Ref.Nr.: BH14743
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