TMS Clinical Trial Administrator

Hobson Prior are looking for an TMS Clinical Trial Administrator to join a world-wide healthcare organisation who offer solutions to address the evolving needs of people all over the world. This role is in Basel on a 2 years contract basis.

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.
• Create and/or update SOPs, Working Practices, Guidance Documents, templates, etc. as applicable.
• Enforce use of standards and adherence to quality by providing training and support to business functions in cooperation with TMF QC Manager.
• Coordinate eDMS Super/Key User community for relevant process area.
• Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.
• May act as Business Administrator in the electronic Document Management System ensuring appropriate user access restriction, accurate and 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.
• Represent as the Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions.

Key Skills:

• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization.
• Excellent communication, organization and tracking skills.
• Fluent English (oral and written), German of advantage.

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.
• 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.
• Advanced ability to work both independently.

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.