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Trial Master File Manager Jobs in Boston, MA (NOW HIRING)

Kura Oncology

Clinical Trial Associate

Boston, MA

$36.50 - $49.75/hr

Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH-GCP and company SOPs. * Track and maintain essential study documentation ...

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.

Verastem

Clinical Trial Manager

Boston, MA

$100K - $125K/yr

Manage assigned clinical trials to ensure that studies are conducted efficiently, on time, within ... Assume responsibility for setting up trial master file and ensuring the trial(s) is "audit ready ...

Alpha-9 Oncology

Clinical Trial Manager

Boston, MA · On-site

Responsible for maintaining internal study documents in the Trial Master File (TMF) and periodically reviewing the CRO TMF for completeness and accuracy. * Support forecasting and management of ...

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$48.3K

$82.1K

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How much do trial master file manager jobs pay per year?

As of Aug 7, 2026, the average yearly pay for trial master file manager in Boston, MA is $82,114.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,300.00 and $101,600.00 per year, depending on experience, location, and employer.

What are some common challenges faced by trial master file managers, and how can they be addressed?

Trial Master File Managers often encounter challenges such as ensuring TMF completeness, maintaining regulatory compliance, and coordinating document submissions across multiple stakeholders. Keeping documents up-to-date and audit-ready requires strong attention to detail and effective communication with clinical teams, vendors, and sponsors. Leveraging electronic TMF systems, implementing standardized processes, and promoting regular training can help address these challenges and ensure the integrity of the TMF throughout a study.

What is a trial master file manager?

A Trial Master File Manager is a professional responsible for overseeing the creation, maintenance, and quality control of the Trial Master File (TMF) in clinical research. The TMF is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. The manager ensures that all documents are complete, accurate, and compliant with regulatory requirements throughout the trial's lifecycle. They work closely with clinical teams, auditors, and regulatory authorities to guarantee readiness for inspections and audits. Their role is crucial for maintaining transparency and credibility in clinical research processes.

What are the key skills and qualifications needed to thrive as a trial master file manager?

To thrive as a Trial Master File Manager, you typically need a strong background in clinical research, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, GCP guidelines, and relevant industry certifications like DIA's TMF Professional Certification is important. Attention to detail, organizational skills, and effective communication help ensure TMF integrity and coordination across cross-functional teams. These skills are crucial for maintaining regulatory compliance, audit readiness, and efficient clinical trial operations.
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Trial Master File Manager jobs near you
Infographic showing various Trial Master File Manager job openings in Boston, MA as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $82,114 per year, or $39.5 per hour.

Director, Trial Master File

Kymera Therapeutics

Watertown, MA • On-site

Full-time

Re-posted 25 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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