Associate II, TMF Operations (LATAM)

Worldwide Clinical Trials; Buenos Aires; Remote; ARS 63,667,000 - 84,890,000; Full time

Job summary

Worldwide Clinical Trials busca un Associate II, TMF Operations para apoyar la integridad del Trial Master File. El rol es remoto y abierto a candidatos en América Latina, con interacción con equipos globales y múltiples zonas horarias. Se espera experiencia TMF y competencias en gestión documental y cumplimiento regulatorio.

Se valorará dominio de herramientas de oficina y sistemas eTMF. El candidato trabajará en la revisión y aprobación de TMF, manejo de documentos electrónicos y en papel, y

Qualifications

• Universidad o grado preferido en disciplina de ciencias de la vida.
• De 1 a 2 años de experiencia TMF en CRO o industria farmacéutica.
• Competencia en inglés con excelentes habilidades de comunicación.
• Experiencia en recopilación de datos, indexación de documentos y nombrado estandarizado.
• Gran atención al detalle y capacidad para gestionar varias tareas con plazos.
• Buena planificación, organización e habilidades interpersonales en entornos dinámicos.
• Dominio de Word y Excel; familiaridad con repositorios electrónicos o sistemas eTMF.

Responsibilities

• Realizar actividades de TMF Approver y TMF Quality Control Reviewer.
• Procesar, revisar y resolver documentos TMF rechazados para estudios complejos.
• Gestionar documentos esenciales en formatos electrónicos y en papel.
• Preparar listas de verificación de control de calidad TMF para revisión del equipo.
• Conducir controles de calidad para cumplir normativas, ICH GCP y expectativas del patrocinador.
• Revisar, clasificar, indexar y procesar documentos en sistemas eTMF electrónicos.
• Aplicar nomenclatura y archivo coherentes para mantener expedientes de ensayo precisos.
• Colaborar con equipos globales para resolver issues de documentación y apoyar la calidad TMF.

Skills

English proficiency

Attention to detail

Multi-tasking

Time management

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Microsoft Excel

eTMF systems

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.