Associate II, TMF Operations (Europe/LATAM)

Worldwide Clinical Trials; United States; A distancia; MXN 979.000 - 1.431.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure essential TMF documents are accurate, complete, and compliant. You will review, process, and quality-check TMF files across studies and sponsor portfolios, applying ALCOA principles and ICH GCP standards.

You will work with global teams, identify TMF trends, resolve issues, and maintain study documentation throughout the lifecycle, with minimal travel and strong collaboration.

Formación

• University degree preferred, Life Sciences, 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, 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.

Responsabilidades

• 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.

Conocimientos

Attention to detail

Communication skills

English proficiency

Planning & organizing

Educación

Bachelor's degree Life Sciences

Herramientas

eTMF system

Microsoft Word

Microsoft Excel

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.