Hobson Prior are looking for a TMF Manager 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.

Job Responsibilities:

• Support the definition and modification of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
• Supervise the process, system and tool landscape that supports the management of outsourced TMFs.
• Promote best documentation practice to line functions and offer direction on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice.
• Ensure deliverables fulfil 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, precise & compliant document creation and document lifecycle management in close partnership 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 organisation.
• Act as Business Lead to manage the implementation of a Next Generation DMS in close alignment other parts of the organisation.

Key Skills:

• Advanced knowledge of clinical documentation and reporting.
• Good understanding of technical processes and PC environment including Microsoft products.
• Knowledge of the national and international data protection legislation.
• Previous involvement with project work or project management in a global organisation.
• Communication, organisation and tracking skills.

Requirements:

• Minimum Bachelor's Degree in Life Science/Healthcare or equivalent
• Fluent English and German is advantageable.
• In-depth knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, 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 exceptional understanding of system structures and generic document management functionality.

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.