Hobson Prior are looking for a TMF Manager - Outsourced Studies to join a world-wide pharmaceutical company based in Switzerland. Our client focuses on providing pioneering medical solutions to improve the quality of people's lives. As the TMF Manager you will be responsible for efficient and appropriate management of Trial Master Files and other TMF related, inspection-relevant documents.

Job Responsibilities:

• 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.
• Represent as a Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions.
• Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.
• May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions.
• Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
• Lead improvement and innovation initiatives in a matrix organization.
• Deliver input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs.

Key Skills:

• Fluent English (oral and written), German of advantage.
• Excellent communication, organization and tracking skills.
• Advanced ability to work both independently.

Requirements:

• 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.
• A minimum of 5 years in clinical development/clinical operations.
• A minimum of 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.
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.