Associate II, TMF Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate II, TMF Operations based in Romania. This role supports the accurate and compliant management of essential clinical trial documentation within a global Clinical Research Organization (CRO) environment. You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations. The position combines document quality control, records management, and collaboration with international clinical project teams. You will contribute directly to data integrity and inspection readiness across complex studies and sponsor portfolios. The role offers exposure to electronic TMF and document management systems while developing your understanding of clinical research operations. Success requires strong attention to detail, organization, and the ability to manage multiple deadline-driven activities with accuracy. It is an excellent opportunity for an early-career professional seeking to build expertise in clinical documentation and TMF operations.

Accountabilities: Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.

Process, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios.

Manage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards.

Prepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members.

Conduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectations, SOPs, and industry best practices.

Work with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.

Apply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready.

Collaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes.

Maintain high standards of accuracy while managing multiple detailed activities within established timelines.

Requirements:

University degree preferred, ideally in Life Sciences or a related discipline.

Up to 1–2 years of relevant experience in TMF operations, records management, clinical research, CRO, pharmaceutical, or a related environment.

General understanding of clinical research principles, clinical trial processes, and the purpose of Trial Master Files.

Experience or demonstrated ability in data collection, indexing, document editing, and applying standardized naming conventions.

Ability to work effectively with electronic document repositories, eTMF platforms, or similar document management systems, with willingness to develop further technical proficiency.

Strong written and verbal communication skills, with the ability to present information clearly, accurately, and concisely.

Exceptional attention to detail and accuracy when handling highly structured and sensitive documentation.

Strong planning, prioritization, and organizational skills, with the ability to manage multiple tasks in a deadline-driven environment.

Proficiency with Microsoft Word and Excel.

Strong interpersonal and collaboration skills, with the ability to work effectively in a fast-paced, changing, and globally distributed environment.

A proactive, reliable, and quality-focused approach to work, with a commitment to following procedures and maintaining compliance.

Benefits:

Opportunity to build specialized experience in TMF operations and clinical research within a global CRO environment.

Exposure to international clinical studies, sponsor portfolios, project teams, and industry best practices.

Hands-on experience with electronic TMF and document management technologies.

Opportunities to collaborate with experienced professionals across clinical research and project teams.

A supportive and inclusive working environment that values collaboration, creativity, and professional development.

Career development opportunities within a global organization focused on improving clinical research and patient outcomes.

An environment committed to equal opportunity, diversity, inclusion, and respectful collaboration.

Meaningful work contributing to the quality, compliance, and integrity of clinical trials that can ultimately improve patients' lives.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1