Associate II, TMF Operations - Europe/Latam- Remote

Worldwide Clinical Trials; Buenos Aires; Presencial; BRL 25 000 - 35 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials in Brazil is seeking candidates for a TMF Operations role. The position involves processing and maintaining essential documents in line with industry regulations. Candidates will perform quality control checks for regulatory adherence and document classification using electronic systems.

The ideal applicant holds a degree in life sciences and has 1–2 years of experience in the CRO/Pharma industry. Proficiency in Microsoft Word and Excel is required, alongside strong communication and organizational skills.

Qualificações

• University Degree preferred (Life Science desirable).
• Up to 1–2 years of relevant TMF experience within the CRO/Pharma industry.

Responsabilidades

• Fulfil the 'TMF Approver' and/or 'TMF QC Reviewer' roles.
• Process, review, and resolve rejected TMF documents.
• Prepare periodic TMF Quality Control checklists for review.
• Perform periodic TMF Quality Control.
• Work with various Electronic Document Management Systems.

Conhecimentos

Data collection, indexing, and editing skills

Excellent written and verbal communication skills

Strong interpersonal skills

Planning and organizational skills

Proficiency in Microsoft Word and Excel

Formação académica

University Degree (Life Science desirable)

Ferramentas

Electronic Document Management Systems

eTMF systems

Descrição da oferta de emprego

What Records Management Compliance Department Does At Worldwide

TMF Operations handles the processing, maintenance, and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country‑specific regulations, and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation propels us in our pursuit of excellence in clinical research and meaningful impact on every patient’s life. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team.

What You Will Do

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
• Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or a Sponsor portfolio of studies in both electronic and hard copy format.
• Prepare periodic TMF Quality Control checklists for review by Project Team.
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.

What You Will Bring To The Role

• Possess data collection, indexing, and editing skills, including the ability to adhere to standardized document naming conventions.
• Possess excellent written and verbal communication skills to clearly and concisely present information.
• Display strong interpersonal skills in a fast‑paced, deadline‑oriented, rapidly changing environment.
• Handle multiple, highly detailed tasks with exceptional accuracy; demonstrate strong planning and organizational skills.
• Demonstrate proficiency in Microsoft Word and Excel.
• Develop proficiency in using an electronic document repository or eTMF. General understanding of clinical research principles and processes.

Your Experience

• University Degree preferred (Life Science desirable).
• Up to 1–2 years of relevant TMF experience within the CRO/Pharma industry.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. 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.