TMF Manager Outsourced Studies
Posted on Oct 13, 2021 by RM IT Professional Resources AG
TMF Manager Outsourced Studies vacancy for a globally operating Basel based company in the pharmaceutical sector.
- 3+ years working experience with document management systems and excellent understanding of system structures and generic document management functionality
- 5+ years of experience in clinical development or clinical operations as well as advanced knowledge of clinical documentation and reporting
- Thorough understanding of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Ability to understand technical processes and PC environment including Microsoft Suite of products as well as good knowledge of the national and international data protection legislation
- Experience with project work or project management in a global, cross-functional multicultural and international Matrix organization
- University degree in Life Science/Healthcare in a relevant field
- Languages: English, fluent in written and spoken, German of advantage
- Supporting the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities
- Overseeing the process, system and tool landscape that supports the management of outsourced TMFs.
- Promoting best documentation practice to line functions and providing guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice
- Ensuring deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
- Acting as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate and compliant document creation and document life cycle management
- Leading improvement and innovation initiatives in a Matrix organization
- Acting as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions
Location: Basel, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV and a contact telephone number on which you are reachable during working hours.
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