Job Title: TMF Manager Outsourced Studies
Duration: 24 month contract
Responsible for efficient and appropriate management of Trial Master Files (TMFs) and other TMF related, inspection-relevant documents from creation through archival in compliance with applicable internal and external requirements for studies with an operational model of outsourced and/or other third party TMFs.
- 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.
- May act as Business Administrator in the electronic Document Management System (eDMS).
- Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
- Compliance of TMF relevant documentation as well as efficiency of related processes.
- Minimum Bachelor’s Degree in Life Science/Healthcare or equivalent
- Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, 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
- Good understanding of technical processes and PC environment including Microsoft suite of products
- Knowledge of the national and international data protection legislation