Associate I, TMF Operations

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Execute the "TMF Approver" duties as specified by the applicable Standard Operating Procedures (SOP) and operational practices.

• Manage, assess, and address rejected Trial Master File (TMF) documents for various studies in both electronic and physical formats.

• Utilize a range of Electronic Document Management and electronic TMF Systems to evaluate, categorize, and process Essential Documents.

• Directly communicate with the RMC Lead to report trends and issues pertaining to the TMF.

• Promptly escalate any TMF Quality concerns to the RMC Lead.

• Offer administrative assistance to the RMC Lead, which includes but is not limited to organizing and maintaining internal documents on the study SharePoint (TMF Quality Control checklists and various trackers).

⛳️ Requirements

• Bachelor's Degree is preferred.

• At least 6 months of pertinent TMF experience.

• Familiarity with operations in a highly regulated environment (ideally within the CRO/Pharma sectors).

🏝️ Benefits

• A diverse and inclusive workplace.

• Opportunities for professionals from various backgrounds.