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Trial Master File Specialist (BE)

25.10.2018 REF: O180120 East of Brussels

Organization

Biopharmaceutical company

Description of the Position

A temporary assignment (3-6 months) to manage the trial master file for one of our clients Clinical Trial.
• Provide qualified GCP Records Management support for Trial Master File (TMF) Records.
• Ensure the management and oversight of TMF activities for paper and electronic documents to ensure delivery of a high quality TMF.
• Serve as a TMF contact for documentation to the project team, and cross functional departments to ensure high quality TMF deliverables are met on time.
• Follow applicable SOP’s to ensure completeness & accuracy of the TMF, as well as, records management tasks, policies, and procedures.
• Obtain and maintain essential documentation in compliance with ICH-GCP.

Demands of the Position

• Fluent knowledge of spoken and written English.
• Vast knowledge of applicable clinical research regulatory requirements/global international records standards to the area of expertise (Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Previous experience of conducting file reviews of Trial Master Files is essential.
• Good knowledge of relevant local regulations.

Terms of Employment

The contract will be a contract with The Clinical Company, you will be outsourced to our client. Within The Clinical Company you will be part of a Benelux team of about 70 enthusiastic clinical professionals under the support of 3 dedicated Clinical Team Managers. The Clinical Company is focused on training, coaching and career development of our clinical professionals.
Interested in this challenge?! For more information, feel free to contact Nick Dufour at 0032 (0)475 87 02 36 or n.dufour@theclinicalcompany.com or apply directly.

Nick for Belgium

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+32 475 87 02 36n.dufour@theclinicalcompany.com

Stijn for the Netherlands

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+316 5364 1197s.valkering@theclinicalcompany.com

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