Worldwide Clinical Trials
Associate II, TMF Operations (LATAM)
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Worldwide Clinical Trials: Records Management (TMF Operations) Compliance Associate / Original
Who We Are
We are Worldwide Clinical Trials, a global, midsize CRO that challenges conventions, drives innovation and pioneers solutions when it comes to tackling the world’s most persistent diseases. Our journey is marked not by those who play it safe, but by bright thinkers, dreamers, and doers bent on transforming how clinical research is conducted. With over 3,500+ experts across continents, our combined efforts are reshaping the face of CROs—for the better.
Our mission: to harness passion and purpose daily and ignite meaningful change in the lives of patients.
Validate our culture and values by joining a team that thrives on diversity, collaboration, creativity, and equality.
Why Worldwide?
We believe progress in patient care is uncertain, driven by the combined efforts of professionals diverse in background, skills and experiences.
- A Thriving Culture: Fostered by accessible leadership and supportive, cohesive teams that embrace inclusion and creativity.
- Work Where You Belong: We value authenticity, encourage teams to empower every individual, and celebrate performative excellence.
- A Unified Community: Every voice makes an impact—inividual gatekeepers, clinical scholars, and innovators—with a common desire to advance medical research.
Be Part Of Something Meaningful: Join a team daring to redefine industries with fresh thinking, precision, and purpose.
About the Role: Records Management Compliance Department
TMF Operations
At Worldwide Clinical Trials, our TMF Operations team ensures compliance, quality and excellence in Trial Master File (TMF) management. This includes:
- Processing, maintenance, archiving, and review of all essential trial documents.
- Adherence to Standard Operating Procedures (SOPs), industry regulations and best practices.
- Embedding collaboration and innovation across a global team working on diverse clinical projects.
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Note: Positions in TMF Operations have a global scope with frequent collaboration across Worldwide’s Project Teams.
Your Responsibilities
Priority: TMF Approval and Quality Control Review
- Fulfill assigned duties as either a “TMF Approver” or “TMF QC Reviewer” per the relevant SOPs and internal workflows.
- Process, evaluate, and resolve rejected TMF documents across complex studies or Sponsor portfolios in both digital (electronic) and hard-copy formats.
- Create and distribute periodic TMF Quality Control checklists for Team reviews.
- Conduct periodic TMF Quality Control (QC) audits ensuring adherence to regulatory guidelines, ICH GCP standards, Sponsor policies, and industry best practice.
- Work with electronic document systems, electronic TMF platforms, and @EDC tools to:
- Review, classify, index, and archive essential documents.
What You’ll Bring to the Role
Core Skills & Experience
- Proven ability to:
- ACCUARTELY collect, index and edit documents—whether structured or unstructured—and organize content per required naming conventions.
- Communicate effectively via written and verbal means, simplifying complex information for diverse audiences.
- Navigate fast-paced teams with sharp interpersonal skills and exceptional attention-to-detail under tight timelines.
- Manage multiple complex, highly-detailed tasks simultaneously with no margin for error.
- Plan and organize efficiently with strong time-management skills.
- Digital literacy:
- Advanced proficiency in Microsoft Word and Excel.
- Skill set for rapidly being proficient with an electronic Document Management (eTMF) system or other pertinent software.
- Basic understanding of clinical research principles and quality processes (ICH GCP, regulatory conformance).
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Education & Experience
- Preferred: Degree holding, especially in Life Science or similar.
- ideal: 1-2 years of relevant TMF experience (gain at CRO, Pharma or academic research).
Bring Purpose to Your Work
Our decisions spark improvements in real lives. We invite professionals proud of their contributions and passionate about achieving measurable impacts in challenging spaces.
A Letter to our Hiring Commit:
We aren’t just looking for talent. We welcome global minds, voices, histories, perspectives, and self-made champions who thrive with purpose.
Start a conversation. Apply today and be part of a community announcing change through scientific excellence.
Visit Worldwide’s Career Hub for more opportunities [Worldwide.com]
Commitment to Diversity & Inclusivity
Worldwide Clinical Trials is dedicated to equal employment opportunity. All decisions and opportunities are considered free from discrimination of race, color, ethnic affiliation, nationality, gender, sex, sexual orientation, pregnancy, parental status, age, disability, religion, military background, or any other characteristic protected by law. To enable inclusion, we foster a workplace powered by creativity, professional growth, and shared success.
Ready To Make a Difference?
At Worldwide Clinical Trials, we do all this by honoring the people—not using them—we serve. If you’re eager to contribute with intelligence, heart, and energy, join our evolving mission today.
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