TMF Specialist – Safety Processing, Min 2 Years Experience in Central File Management

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

📋 Description

• Manage TMF documents received in accordance with good documentation practices, TMF readiness criteria, and other relevant guidelines.

• Exhibit a comprehensive understanding of document types, their properties, and indexing requirements.

• Ensure the overall quality of the TMF by validating document completeness, indexing accuracy, and scanning precision.

• Process documents in the TMF system(s) within designated timelines, prioritizing based on document criticality.

• Address document inquiries with the appropriate users as necessary.

• Collaborate with Document Owners, TMF Study Owners, and other end users to rectify document-related discrepancies and issues.

• Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations as required.

• Participate in process improvement initiatives and projects that may arise.

⛳️ Requirements

• A minimum of a Bachelor’s degree or equivalent qualification.

• At least 2 years of relevant experience in central file management for clinical trials.

• Experience in the pharmaceutical industry or at a CRO in a comparable position.

• Proven experience working in a global setting, as the role necessitates communication with the Asia-Pacific team.

• Strong understanding of ICH/GCP document requirements.

• Excellent verbal and written communication skills with both internal and external teams.

• High level of technical proficiency and the capacity to learn and utilize various systems.

🏝️ Benefits

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Opportunities for peer recognition.

• Comprehensive total rewards program.