Associate I – TMF Operations

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

📋 Description

• Assume the role of "TMF Approver" as outlined by the corresponding Standard Operating Procedure(s) (SOP) and established practices.

• Process, evaluate, and resolve any rejected Trial Master File (TMF) documents for multiple studies in both electronic and hard copy formats.

• Collaborate with various Electronic Document Management and electronic TMF Systems to review, categorize, and handle Essential Documents.

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

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

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

• Carry out additional tasks as directed by the Line Manager.

⛳️ Requirements

• A University Degree is preferred.

• At least 6 months of relevant experience in TMF.

• Familiarity with operating in a highly regulated industry (ideally within CRO/Pharma sectors).

• Strong skills in data collection, indexing, and editing, with the ability to follow standardized document naming conventions.

• Excellent written and verbal communication skills to effectively present information in a clear and concise manner.

• Ability to collaborate with internal teams and execute tasks under general supervision, seeking help as necessary.

• Good judgment and the capability to identify decisions that require supervisory approval.

• Proficient in Microsoft Word and Excel.

• Ability to develop proficiency in using an electronic document repository or eTMF, along with document recognition skills.

• A general understanding of clinical research principles and processes.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events