TMF Lead II

This is a fully remote position, open to applicants in Argentina, +1 more country.

📋 Description

• Carry out management activities for electronic and/or paper Trial Master File records.

• Take the lead in establishing, maintaining, and concluding TMFs, including developing and owning study TMF Plans and indexes.

• Execute TMF transitions and utilize Sponsor TMF processes and systems.

• Offer oversight, training, KPI analysis, and reporting on TMF status.

• Recognize and resolve TMF quality and completeness issues that impact audit and inspection readiness.

• Serve as the primary TMF contact for project teams, Sponsors, auditors, and other third-party stakeholders.

• Collaborate directly with records specialists assigned to specific studies.

• Partner with the eTMF Administrator to address system-related challenges.

• Review the TMF scope of work and pinpoint out-of-scope activities for potential change-orders.

• Deliver regular TMF status updates to Project Leadership and Functions.

• Assist in overseeing security, environment, and access control within Secure File Room facilities.

• Ensure compliance with TMF SOPs and TMF Plans.

• Conduct live, web-based, and recorded training on TMF processes and systems.

• Execute departmental budgeted tasks for assigned studies.

• Create, sign, and uphold TMF Plans, TMF Transition Plans, and indexes.

• Engage in TMF audits and inspections as the TMF representative.

• Coordinate quality reviews of TMFs with the project team.

⛳️ Requirements

• A minimum of a high school diploma or its international equivalent is required.

• An undergraduate degree from an accredited institution in records and information management, library science, or a related field in clinical science or health is preferred.

• Experience equivalent to clinical trials records management may be accepted as an alternative to the preferred undergraduate degree.

• A minimum of 8 years of experience with eTMF systems is required.

• At least 8 years of Trial Master File management experience is essential.

• A minimum of 8 years of experience with the TMF Reference Model is required.

• At least 2 years of experience in a TMF Lead role is necessary.

• Familiarity with ICH-GCP, ISO14155, FDA CFR Part 11, and global regulations pertaining to the investigational drug and device industry is required.

🏝️ Benefits

• Flexibility and balance to support your lifestyle.

• Opportunities for professional growth and career development.