TMF Operations Manager

Responsibilities:

• Responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File (TMF).
• Lead TMF quality review activities, including ongoing completeness checks ensuring that all required documents are accurately filed.
• Liaison to the CRO TMF team, responsible for ongoing review of reported KPIs and reports.

Qualifications:

• Bachelor's degree or equivalent combination of education and experience in science or health related field.
• Minimum 5 years of clinical operations experience, including global trial experience.
• Thorough knowledge of the CDISC TMF Reference Model, ALCOA+ standards, Good Documentation Practices, and FDA/EMA/MHRA regulations.

Skills:

• Experience with eTMF systems (eg, Medidata RCM, Trial Interactive) that includes but not limited to development of training materials, SOPs, performing UATs and change control management.
• Ability to independently engage in cross-functional interactions with internal and external staff.
• General knowledge of clinical trials and basic principles of overall trial planning and execution.