Associate II, TMF Operations (Europe/LATAM)
Job description
An Associate II, TMF Operations role at a global contract research organization, responsible for reviewing, processing, and quality-checking Trial Master File documentation across complex studies or sponsor portfolios. The position supports document quality and compliance with ALCOA principles, regulations, ICH GCP, and industry best practices.
At a glance
- Work mode
- Remote · Europe
- Languages
- English – fluent
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 we're looking for
- 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.
- 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.
Nice to have
- Knowledge of working within a highly regulated industry is desirable.
Your team
TMF Operations
A global TMF Operations team ensuring essential clinical trial documentation is complete, accurate, and maintained to the required standards.
Apply
About Worldwide Clinical Trials
Where innovation meets purpose
A global Contract Resource Organization (CRO) with more than 4,000 professionals across the globe, fostering a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact.
Mission
Improving lives through high-quality clinical research
Key facts
- more than 4,000 professionals
- Clinical research
- Global Contract Resource Organization (CRO)
- More than 4,000 professionals across the globe
What they value
- Diverse perspectives
- Growth
- Ownership