Team Lead, TMF Operations

This is a fully remote position, open to applicants in Croatia.

📋 Description

• Accountable for ensuring Trial Master Files are inspection-ready in accordance with applicable Standard Operating Procedures, ALCOA principles, local regulations, and industry best practices.

• Lead the achievement of Project Team goals by managing essential documentation effectively.

• Oversee the provision of TMF Services for 5-10 studies.

• Track Key Performance Indicators and relay performance updates to Project Teams (PT) and Sponsors.

• Recognize critical risks and implement strategies to mitigate them.

• Evaluate and interpret data to support informed, data-driven decision-making.

• Create project-specific Quality Management Documents (QMDs).

⛳️ Requirements

• Preferred University Degree (desirable in Life Sciences).

• A combination of education and 3-5 years of relevant experience.

• Thorough understanding of ICH GCP.

• Experience in assisting with GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.).

• Familiarity with Document Management and/or eTMF solutions (e.g., Veeva, Trial Interactive, Documentum, etc.).

• Practical knowledge of operating within highly regulated industries (desirable).

🏝️ Benefits

• We emphasize fostering a diverse and inclusive environment that encourages collaboration and innovation.