Associate II, TMF Operations

Jobgether; Brasil; Remote; BRL 60,000 - 90,000; Full time

Benefits offered by this job

Remote work in Brazil

Full-time employment

No travel

Global collaboration with teams

Job summary

Jobgether is listing an Associate II, TMF Operations based in Brazil for a remote role supporting TMF doc quality and regulatory compliance across studies. You will review, process, and quality-check TMF/eTMF records using SOPs and ALCOA principles, collaborating with global teams to ensure inspection-ready documentation throughout the lifecycle.

The ideal candidate has a Life Sciences background, 1–2 years of related experience, and strong English communication.

Qualifications

• University degree preferred in Life Sciences with 1–2 years of related experience.
• Strong written and verbal English communication.
• Experience with electronic TMF repositories and indexing.
• Understanding of ICH GCP and regulatory requirements is a plus.
• Ability to follow SOPs and maintain ALCOA principles.
• Attention to detail and ability to work independently within a regulated environment.
• Collaborative mindset across global teams and time zones.

Responsibilities

• Review and approve TMF documents per SOPs and quality standards.
• Process and resolve rejected TMF records across multiple studies.
• Perform periodic TMF quality control checks for regulatory compliance.
• Create TMF QC checklists and maintain study documentation trackers.
• Manage documents using electronic repositories and eTMF systems.
• Ensure naming conventions and dependencies are correct in the eTMF.
• Identify trends and escalate quality concerns to RMC Lead.
• Support SharePoint documentation and deputy coverage as needed.
• Collaborate with global teams to resolve documentation discrepancies.
• Maintain inspection-ready records throughout the document lifecycle.

Skills

Attention to detail

English proficiency

eTMF experience

Documentation review

SOP compliance

Education

University degree in Life Sciences

Tools

eTMF systems

Microsoft Word

Microsoft Excel

Job description

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Associate II, TMF Operations based in Brazil.

We are seeking a detail-oriented Associate II, TMF Operations professional to support the quality, accuracy, and compliance of essential clinical trial documentation. In this remote role, you will review, process, and quality-check Trial Master File (TMF) documents across clinical studies and sponsor portfolios, helping ensure that records meet regulatory requirements and established quality standards. You will work with electronic Trial Master File (eTMF) systems and document management platforms to maintain complete, accurate, and well-organized clinical records. Collaborating with global project teams and records management colleagues, you will identify documentation issues, resolve rejected files, and support continuous quality improvement. Your work will contribute to the integrity of clinical research and help ensure that trial documentation remains inspection-ready throughout the document lifecycle. This opportunity is well suited to an organized professional who values accuracy, teamwork, and compliance in a regulated environment.

Accountabilities

• Review and approve essential Trial Master File (TMF) documents in accordance with applicable standard operating procedures (SOPs), work instructions, and established quality standards.
• Process, review, and resolve rejected TMF documents across complex clinical studies and sponsor portfolios, working with both electronic and hard-copy records.
• Conduct periodic TMF quality control reviews to verify compliance with regulatory requirements, International Council for Harmonisation Good Clinical Practice (ICH GCP), sponsor expectations, and industry best practices.
• Prepare TMF quality control checklists for project team review and maintain associated study documentation, trackers, and records.
• Use electronic document management repositories and eTMF systems to review, classify, index, process, and maintain essential clinical trial documentation accurately.
• Ensure document management activities follow applicable SOPs, ALCOA principles, country-specific regulations, and established document handling practices.
• Identify trends, recurring issues, and documentation quality concerns, communicating findings to the relevant Records Management and Compliance (RMC) Lead and escalating issues when necessary.
• Support the RMC Lead with study-related SharePoint documentation, administrative tasks, and deputy coverage as required.
• Verify document naming conventions, cross-checks, and dependencies within the eTMF to support consistency, traceability, and completeness.
• Collaborate with global project team members to resolve documentation discrepancies and maintain high standards throughout the clinical trial document lifecycle.

Requirements

• A university degree is preferred, ideally in Life Sciences, together with approximately 1–2 years of relevant professional experience.
• Proficiency in English, with strong written and verbal communication skills.
• Experience using an electronic document repository or eTMF system, including document recognition, data collection, indexing, review, and editing.
• A general understanding of clinical research principles and processes; experience in a highly regulated industry is an advantage.
• Knowledge of essential clinical trial documentation, document management practices, and quality control procedures is beneficial.
• Ability to understand document cross-checks and dependencies within an eTMF and consistently follow standardized document naming conventions.
• Strong attention to detail and a commitment to maintaining accurate, complete, and compliant records.
• Excellent planning and organizational skills, with the ability to manage multiple detailed tasks and meet deadlines in a changing work environment.
• Sound judgment and the ability to work independently under general direction while recognizing when guidance or escalation is needed.
• Proficiency in Microsoft Word and Excel, with the ability to follow applicable SOPs and sponsor-specific procedures.
• A collaborative approach and the ability to communicate effectively with project teams and colleagues across different locations and time zones.
• Flexibility and adaptability when responding to changing study priorities and documentation requirements.

Benefits

• Remote work arrangement for eligible candidates based in Brazil.
• Full-time employment opportunity.
• No travel required.
• Opportunity to develop expertise in clinical trial documentation, TMF operations, and eTMF systems.
• Exposure to international clinical research projects and collaboration with global teams.
• Opportunities to strengthen knowledge of ICH GCP, regulatory compliance, document quality control, and clinical research standards.
• Experience working in a structured, quality-focused environment supporting clinical research and the development of new therapies.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice:

By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1