Associate II, TMF Operations (Europe)

Worldwide Clinical Trials; United States; A distancia; USD 58.000 - 67.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials seeks an Associate II, TMF Operations for a remote role open to Europe-based candidates. You will review, process, and quality-check TMF documentation across studies, ensuring ALCOA-aligned records and regulatory compliance with ICH GCP standards.

You will collaborate with global teams, support RMC Leads, and maintain study documentation across multiple time zones with careful attention to quality and timelines.

Formación

• University degree preferred, ideally in Life Sciences.
• Proficiency in English with strong written and verbal communication skills.
• Experience using an electronic document repository or eTMF with indexing and editing skills.
• General understanding of clinical research principles and processes in a highly regulated industry.
• Strong attention to detail; ability to manage multiple tasks to deadlines.
• Strong planning and organizational skills; able to work with limited direction.
• Proficiency in Word and Excel; follow standard operating procedures.

Responsabilidades

• Review and approve essential TMF documents per 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 regulatory compliance.
• Prepare TMF Quality Control checklists for Project Team review and tracking.
• Use electronic document management and eTMF systems to review, classify, and process documents.
• Identify TMF trends, issues, and quality concerns to the RMC Lead and escalate when needed.
• Support the RMC Lead with study SharePoint documentation and other administrative tasks; deputise when required.
• Maintain essential documents in accordance with SOPs, ALCOA principles, country regulations, and established practices.

Conocimientos

English proficiency

Attention to detail

Documentation management

eTMF experience

Regulatory knowledge

Educación

University degree in Life Sciences

Descripción del empleo

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

• A university degree is preferred, ideally in Life Sciences, combined with up to 1–2 years of relevant experience.
• Proficiency in English, with strong written and verbal communication skills.
• Experience using an electronic document repository or eTMF, together with strong document recognition, data collection, indexing, and editing skills.
• 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.
• Strong planning and organizational skills, sound judgment, and the ability to work effectively under general direction while seeking support when needed.
• Ability to understand document cross-checks and dependencies within an eTMF and follow standardized document naming conventions.
• Proficiency in Microsoft Word and Excel, with the ability to understand and follow applicable Worldwide and sponsor standard operating procedures.

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.