Hobson Prior are currently seeking for a Trial Master File Specialist to join a fantastic biotech organisation on a contract basis located in Mechelen. Our client is focused on the unmet medical needs.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will serve as the SME and guarantee precise set-up, upkeep and filing of the TMF.
• Instigate pertinent plans and tools, monitoring the content, arranging and assisting quality evaluations of the TMF, assuring constant audit/inspection readiness.
• Communicate and decide together with leaders on the risk-based approach and the TMF quality, both for vendor and company.
• Assist CST-members to always guarantee that audit/inspection readiness of allocated study(ies).
• Guarantee that suitable filing of TMF components from all pertinent shareholders, as well as the smooth transfer of vendor TMF components into the business's TMF and suitable archiving of the TMF.
• Any other assigned duties.

Requirements:

• Educated to an advanced degree level in a life science or corresponding through experience.
• Comprehension of drug development and GDPs.
• Acquaintance with set-up, management, close-out and quality control of TMFs.
• Prior involvement in a leadership role, ideally within a matrix managed setting.
• Capable of adapting to corporate culture.
• Communication skills both verbally and in writing.
• Fluency in the English language.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.

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