TMF Team Lead – EMEA/LATAM (Remote, Fixed-term)

About the role

We are seeking a TMF Team Lead to oversee Trial Master File (TMF) operations across EMEA and LATAM studies. This fixed‑term, remote position ensures inspection readiness and compliance with SOPs, regulations and industry best practice.

Key responsibilities

• Maintain TMF inspection readiness in line with SOPs, ALCOA principles and country regulations.
• Facilitate delivery of TMF services for 5‑10 studies, coordinating with project teams, sponsors and CROs.
• Monitor key performance indicators, report performance to project teams and sponsors, and identify and mitigate risks.
• Analyze data to support data‑driven decisions and develop project‑specific Quality Management Documents.
• Provide guidance on TMF issues and support GCP inspections (FDA, EMA, etc.).

Required profile

• University degree (Life Science preferred) with 3‑5 years of relevant experience.
• In‑depth knowledge of ICH GCP and experience supporting GCP inspections.
• Strong analytical and critical‑thinking abilities to evaluate complex situations.
• Excellent interpersonal skills in a fast‑paced, deadline‑driven environment.
• Ability to mentor, train and manage direct reports.
• Proven capability to handle detailed tasks accurately under pressure.

Required skills

• ICH GCP
• eTMF solutions (e.g., Veeva)
• Document Management systems

What we offer

• Opportunity to work with a global CRO on high‑impact clinical studies.
• Remote work flexibility.
• Fixed‑term contract with potential for extension.