Associate 2 - TMF Operations

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. 

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. 

Make an Impact as a Associate II, TMF Operations at Worldwide

Join a global TMF Operations team where your attention to detail and commitment to quality will help ensure essential clinical trial documentation is complete, accurate, and maintained to the required standards.

As an Associate II, TMF Operations, you’ll take ownership of reviewing, processing, and quality-checking Trial Master File (TMF) documentation across complex studies or sponsor portfolios. Your work will support strong document quality and compliance with applicable procedures, ALCOA principles, regulations, ICH GCP, and industry best practices.

You’ll collaborate with Worldwide Project Team members across the globe, working with RMC Leads and internal teams to identify TMF trends, resolve issues, and maintain high standards throughout the document lifecycle.

Where You'll Work

This is a remote role open to candidates based in Europe. You will collaborate with global teams across multiple time zones.

No travel is required.

What You'll Do

• Review and approve essential TMF documents in line with relevant SOPs and working practices.
• Process, review, and resolve rejected TMF documents across complex studies or sponsor portfolios in electronic and hard-copy formats.
• Perform periodic TMF Quality Control reviews to support compliance with regulatory requirements, ICH GCP, sponsor expectations, and industry best practices.
• Prepare TMF Quality Control checklists for Project Team review and maintain associated study documentation and trackers.
• Use electronic document management and eTMF systems to review, classify, and process essential documents accurately.
• Identify and communicate TMF trends, issues, and quality concerns to the RMC Lead, escalating issues promptly when required.
• Support the RMC Lead with study SharePoint documentation and other administrative activities, and provide deputy coverage when required.
• Maintain essential documents in accordance with applicable SOPs, ALCOA principles, country regulations, and established document management practices.

What You'll Bring

• At least 2 years of hands-on experience in eTMF
• Strong skills in document recognition, data collection, indexing, performing TMF completeness and quality checks across complex studies
• General understanding of clinical research principles and processes (knowledge of working within a highly regulated industry is desirable)
• Strong attention to detail, with the ability to manage multiple detailed tasks accurately in a deadline-oriented and rapidly changing environment.
• Ability to understand document cross-checks and dependencies within an eTMF and follow standardized document naming conventions.
• Proficiency in Microsoft Word and Excel
• Proficiency in English, with strong written and verbal communication skills.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.