Senior Associate I, TMF Operations

Accountabilities: The Senior Associate I, TMF Operations will oversee Trial Master File activities, ensuring essential clinical documents are accurately managed, maintained, and compliant with applicable regulations and quality standards. This role requires strong organizational skills, collaboration with internal and external stakeholders, and the ability to manage multiple priorities in a fast-paced clinical research environment.

Perform TMF operational activities across multiple complex clinical studies or sponsor portfolios.

Collaborate directly with project teams and sponsors to assess documentation needs and provide subject matter expertise on TMF processes.

Manage and support quality control activities, including planning, reporting, tracking, and follow-up of compliance issues.

Assist in the creation and maintenance of study-specific TMF quality management documentation.

Prepare, maintain, and present TMF key performance indicators (KPIs) and data analysis trends to project teams and sponsors.

Support regulatory inspections, sponsor audits, and resolution of audit findings when required.

Ensure documentation practices align with applicable regulations, standard operating procedures, and industry best practices.

Identify operational challenges and recommend compliant solutions for complex documentation and process-related situations.

Contribute to continuous improvement initiatives within records management and clinical operations processes.

Requirements:

The ideal candidate has experience in clinical research, regulated industries, or Trial Master File management, with strong attention to detail and the ability to communicate effectively with diverse stakeholders. They should be comfortable working independently while managing deadlines and quality expectations.

University degree preferred, ideally in Life Sciences or a related discipline.

1–3 years of relevant experience in clinical research, pharmaceutical, CRO, or another highly regulated industry.

Strong understanding of clinical research principles, TMF management practices, industry standards, and regulatory requirements.

Excellent planning, organizational, and prioritization skills with the ability to manage multiple projects under pressure.

Strong written and verbal communication skills, with the ability to clearly present information to internal and external stakeholders.

Ability to analyze situations, identify solutions, and make informed decisions while maintaining regulatory compliance.

Strong interpersonal skills and ability to collaborate effectively in a global, fast-paced environment.

Ability to work independently and demonstrate increasing levels of responsibility and ownership.

Experience supporting audits, quality reviews, or compliance activities is highly valued.

Benefits:

Full-time remote position with flexibility for professionals based in Brazil.

Opportunity to contribute to impactful clinical research programs that improve patient outcomes.

Collaboration with global teams and experienced professionals across clinical research functions.

Inclusive and supportive work environment focused on collaboration, innovation, and professional growth.

Opportunities to develop expertise in TMF operations, compliance, and clinical trial management.

Access to professional development opportunities and career growth pathways.

Opportunity to work within a global organization dedicated to advancing healthcare solutions.

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? 

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