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Trial Master File Associate Jobs in Massachusetts

Kura Oncology

Clinical Trial Associate

Boston, MA

$36.50 - $49.75/hr

Job Summary: The Clinical Trial Associate (CTA) supports the operational execution of clinical ... Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness ...

Verastem

Clinical Trial Associate

Boston, MA

$36.50 - $49.75/hr

Manages trial related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users.

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
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Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Massachusetts as of July 2026, with employment types broken down into 1% As Needed, 69% Full Time, 25% Part Time, 4% Temporary, and 1% Contract. Highlights an 96% Physical, 2% Hybrid, and 2% Remote job distribution.
Director, Trial Master File

Director, Trial Master File

Kymera Therapeutics

Watertown, MA • On-site

Full-time

Posted 15 days ago

Job description

Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
  • PIONEER: We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.
  • COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
  • BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you'll make an impact:
  • Lead end-to-end implementation and configuration of the Trial Master File (TMF/eTMF) platform, including system setup, role-based access, workflows, and integration with clinical systems to ensure compliance with regulatory and inspection-readiness standards.
  • Develop, standardize, and implement TMF business processes, SOPs, governance models, and operational workflows across clinical programs, partnering with Clinical Operations, Quality, Regulatory, and IT teams to drive consistent adoption, process efficiency, and scalable execution.
  • Provide strategic and operational leadership for the end-to-end management of the Trial Master File (TMF) across all clinical studies, ensuring inspection readiness throughout the trial lifecycle.
  • Serve as the TMF subject matter expert for the organization, providing guidance to Clinical Operations, Regulatory, Quality, and cross-functional study teams on essential document requirements and best practices.
  • Lead oversight of eTMF systems and service providers, ensuring vendor performance, compliance with contractual obligations, and alignment with sponsor expectations for TMF management.
  • Establish and monitor TMF performance metrics and dashboards (e.g., completeness, timeliness, quality trends), proactively identifying risks and driving corrective actions.
  • Partner closely with Clinical Operations and study teams to ensure TMF activities are integrated into study planning and execution, from study start-up through close-out and inspection readiness.
  • Ensure TMF readiness to support audits, inspections, and regulatory submissions, acting as a central point of contact during TMF-related inspection activities.
  • Lead and execute TMF QC and periodic review activities, including oversight of completeness checks, quality issues, root-cause analysis, and CAPA development.
  • Define and drive TMF training and enablement for internal staff and vendors, ensuring consistent understanding of filing responsibilities and expectations.
  • Maintain alignment between TMF practices and clinical trial oversight, vendor oversight, and protocol deviation management, ensuring documentation supports sponsor oversight obligations.
  • Lead or contribute to continuous improvement initiatives to enhance TMF quality, efficiency, and inspection readiness, including process simplification and system optimization.
  • Ensure timely and compliant TMF close-out, transfer, and archival, including oversight of final reconciliation activities and long-term record retention requirements.

Skills and experience you'll bring:
  • 10+ years of experience in the biotech/pharmaceutical industry with direct experience in TMF management and eTMF system implementation.
  • Proven track record in process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
  • Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
  • Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
  • Proven track record of managing multiple projects and/or programs concurrently
  • Excellent analytical, problem-solving, and organizational skills.
  • Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
  • Demonstrated ability to lead change and foster a culture of continuous improvement.

Equal Employment Opportunity
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
  • Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
  • The anticipated base salary range for this role is $195,000 - $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
  • Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

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