Associate II, TMF Operations

This is a fully remote position, open to applicants in Spain, +3 more states.

📋 Description

• Execute the roles of "TMF Approver" and/or "TMF QC Reviewer" as outlined in the applicable Standard Operating Procedures (SOP) and operational practices.

• Review, process, and address rejected Trial Master File (TMF) documents for intricate studies or a portfolio of studies for the Sponsor, in both electronic and hard copy formats.

• Create periodic TMF Quality Control checklists for assessment by the Project Team.

• Conduct regular TMF Quality Control to ensure compliance with regulatory standards, ICH GCP, Sponsor requirements, and industry best practices.

• Collaborate with various Electronic Document Management and electronic TMF Systems to assess, classify, and process Essential Documents.

⛳️ Requirements

• 2-3 years of relevant experience with TMF in the CRO/Pharma sector.

• Preferred University Degree (Life Sciences is desirable).

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

• Excellent written and verbal communication skills to present information clearly and concisely.

• Strong interpersonal skills in a dynamic, deadline-driven, and rapidly evolving environment.

• Ability to manage multiple, highly detailed tasks with outstanding accuracy.

• Strong planning and organizational skills.

• Proficient in Microsoft Word and Excel.

• Ability to develop proficiency in the use of an electronic document repository or eTMF.

• General understanding of clinical research principles and processes.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options