Associate II, TMF Operations

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

📋 Description

• Execute the roles of 'TMF Approver' and/or 'TMF QC Reviewer' in accordance with applicable SOPs and operational practices.

• Assess, review, and address rejected Trial Master File documents for intricate studies or Sponsor portfolios in both electronic and physical formats.

• Create regular TMF Quality Control checklists for the Project Team's evaluation.

• Conduct periodic TMF Quality Control assessments to ensure compliance with regulatory, ICH GCP, Sponsor, and industry best practices.

• Analyze, categorize, and manage Essential Documents utilizing Electronic Document Management and electronic TMF systems.

⛳️ Requirements

• Skills in data collection, indexing, and editing.

• Capability to follow standardized document naming conventions.

• Outstanding written and verbal communication abilities.

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

• Capacity to manage multiple, highly detailed tasks with exceptional accuracy.

• Strong planning and organizational capabilities.

• Proficiency in Microsoft Word and Excel.

• Ability to gain proficiency in an electronic document repository or eTMF.

• General knowledge of clinical research principles and processes.

• Up to 1–2 years of relevant TMF experience within the CRO/Pharma sector.

• University Degree preferred; a background in Life Science is desirable.

🏝️ Benefits

• A diverse and inclusive work environment.

• Equal employment opportunities.

• Exceptional employee experiences.

• Supportive and cohesive teams.

• Hands-on, accessible leadership.

• Opportunities to collaborate with global Worldwide Project Teams.