TMF Manager Outsourced Studies
Posted on Aug 15, 2019 by RM IT Professional Resources AG
TMF Manager Outsourced Studies for a globally operating Basel based company in the pharmaceutical sector.
. 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
- 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.
Location: Basel, Switzerland
Did this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number.
As a preferred recruitment agency for Swiss banks, international insurance, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern and other regions in Switzerland every day.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more