Associate II, TMF Operations (LATAM)

Worldwide Clinical Trials; United States; Remote; MXN 240,000 - 420,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure Trial Master File documents are accurate, complete, and inspection-ready across complex studies. You will manage TMF documentation in electronic and hard-copy formats and support quality control activities.

This remote role is open to candidates based in Latin America. You will collaborate with global teams across time zones and contribute to regulatory compliance, ICH GCP standards, and industry best practices while

Qualifications

• University degree preferred, life sciences.
• Up to 1–2 years TMF experience within CRO/pharma.
• Proficiency in English, with excellent written and verbal communication.
• Experience in data collection, document indexing, editing, and standardized document naming.
• Strong attention to detail, with ability to manage multiple tasks and meet deadlines.
• Effective planning, organizational, and interpersonal skills in a fast-paced environment.
• Proficiency in Microsoft Word and Excel.
• Familiarity with electronic document repositories or eTMF systems.

Responsibilities

• Perform TMF Approver and TMF Quality Control Reviewer activities per procedures.
• Process, review, and resolve rejected TMF documents for complex studies.
• Manage essential documents in electronic and hard-copy formats.
• Prepare periodic TMF Quality Control checklists for project team review.
• Conduct regular quality checks to support regulatory compliance, ICH GCP, sponsor expectations.
• Review, classify, index, and process essential documents using eTMF systems.
• Apply consistent document naming and filing standards to maintain high-quality records.
• Collaborate with global project teams to address documentation issues and support TMF quality.

Job description

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Make an Impact as an Associate II, TMF Operations at Worldwide

Help maintain the quality and integrity of clinical research by ensuring essential Trial Master File documents are accurate, complete, and managed in line with regulatory and industry standards.

You will take ownership of document processing, review, and quality control activities across complex studies or sponsor portfolios. Your attention to detail will support inspection‑ready TMFs and help project teams deliver research that makes a meaningful impact on patients’ lives.

As part of a globally focused team, you will collaborate with Worldwide project teams and work with a range of electronic document management and eTMF systems.

Where You'll Work

This is a remote role open to candidates based in Latin America. You will collaborate with global teams across multiple time zones.

What You'll Do

• Perform TMF Approver and TMF Quality Control Reviewer activities in accordance with relevant procedures and working practices.
• Process, review, and resolve rejected TMF documents for complex studies or sponsor portfolios.
• Manage essential documents in electronic and hard-copy formats.
• Prepare periodic TMF Quality Control checklists for project team review.
• Conduct regular quality checks to support compliance with regulatory requirements, ICH GCP, sponsor expectations, and industry best practices.
• Review, classify, index, and process essential documents using electronic document management and eTMF systems.
• Apply consistent document naming and filing standards to maintain accurate, high-quality trial records.
• Collaborate with global project teams to address documentation issues and support TMF quality.

What You'll Bring

• A university degree is preferred, ideally in a life science discipline.
• Up to one to two years of relevant TMF experience within the CRO or pharmaceutical industry.
• Proficiency in English, with excellent written and verbal communication skills.
• Experience in data collection, document indexing, editing, and standardized document naming.
• Strong attention to detail, with the ability to manage multiple tasks accurately and meet deadlines.
• Effective planning, organizational, and interpersonal skills in a fast‑paced, changing environment.
• Proficiency in Microsoft Word and Excel.
• Familiarity with electronic document repositories or eTMF systems, together with a general understanding of clinical research principles and processes.

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.