At a Glance
- Tasks: Review and manage essential clinical trial documentation with a focus on quality and compliance.
- Company: Join a global CRO dedicated to improving lives through innovative clinical research.
- Benefits: Remote work, collaborative culture, and opportunities for personal and professional growth.
- Other info: Dynamic remote role with no travel needed, perfect for aspiring professionals.
- Why this job: Make a real impact in clinical research while working with diverse global teams.
- Qualifications: 2 years of eTMF experience and strong attention to detail required.
The predicted salary is between 36900 - 45100 £ per year.
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 e TMF 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 Share Point 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 e TMF
- 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 e TMF 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
- Linked In
Associate II, TMF Operations (Europe) employer: Worldwide Clinical Trials
Worldwide Clinical Trials is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals passionate about clinical research. With a strong emphasis on employee growth, the company offers numerous opportunities for skill development and career advancement, all while working in a diverse environment that values creativity and teamwork. Located in a vibrant area, employees benefit from a supportive atmosphere that encourages meaningful contributions to patient engagement activities.
