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Trial Master File Manager Jobs in Massachusetts (NOW HIRING)

Clinical Trial Associate

Boston, MA ยท On-site

$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.

Clinical Trial Manager

Waltham, MA ยท On-site +1

$140K - $200K/yr

Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) * Contribute to growth and development of clinical operations function via process/SOP review and ...

Clinical Trial Manager

Waltham, MA ยท On-site

$140K - $200K/yr

Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) * Contribute to growth and development of clinical operations function via process/SOP review and ...

Clinical Trial Manager

Boston, MA ยท On-site

$100 - $125/hr

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 ...

New

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 ...

Senior Clinical Trial Manager

Cambridge, MA ยท On-site

$142K - $176K/yr

As the Senior Clinical Trial Manager, you will be responsible for the day-to-day management of our ... up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial ...

As the Senior Clinical Trial Manager, you will be responsible for the day-to-day management of our ... up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial ...

Senior Clinical Trial Manager

Cambridge, MA ยท On-site

$142K - $176K/yr

As the Senior Clinical Trial Manager, you will be responsible for the day-to-day management of our ... up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial ...

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 ...

Clinical Trial Manager

Boston, MA ยท On-site

$100K - $125K/yr

Assume responsibility for setting up trial master file and ensuring the trial(s) is "audit ready ... Global Phase 3 clinical trial management experience * Minimum of 3 years of clinical trial ...

Clinical Trial Manager

Cambridge, MA ยท On-site

$140 - $168/hr

Manage the operational aspects of clinical trials (e.g., study management, site monitoring and management, trial master file (TMF) oversight) * Coordinate and support regulatory submissions and ...

Trial Master File and inspection readiness * Maintain oversight of study TMF completeness and ... Manage vendor deliverables and timelines, escalate risks, and track issue resolution. Required ...

Senior Clinical Trial Manager

Waltham, MA ยท On-site

$130 - $180/hr

Trial Master File and inspection readiness * Maintain oversight of study TMF completeness and ... Manage vendor deliverables and timelines, elevate risks, and track issue resolution. Required ...

Showing results 21-40

Trial Master File Manager information

See Massachusetts salary details

$48.6K

$82.5K

$124.5K

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

As of Sep 4, 2026, the average yearly pay for trial master file manager in Massachusetts is $82,547.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,600.00 and $102,100.00 per year, depending on experience, location, and employer.

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.

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 are the most commonly searched types of Trial Master File jobs in Massachusetts?

The most popular types of Trial Master File jobs in Massachusetts are:

What job categories do people searching Trial Master File Manager jobs in Massachusetts look for?

The top searched job categories for Trial Master File Manager jobs in Massachusetts are:

What cities in Massachusetts are hiring for Trial Master File Manager jobs?

Cities in Massachusetts with the most Trial Master File Manager job openings:

Associate Director, Trial Operations & Budget

AdvanCell

Boston, MA โ€ข On-site

$123K - $154K/yr

Full-time

Re-posted 5 days ago


Job description

The Associate Director, Trial Operations & Budget is responsible for supporting the oversight, planning, and execution of clinical trial activities, with a strong emphasis on financial management and operational excellence. This role ensures that clinical operations deliverables related to CROs, vendors, and clinical sites management and oversight, including budgeting, contracting, invoicing, and Trial Master File (TMF) quality and completeness verification-are conducted in alignment with corporate financial and clinical operations SOPs, study protocols, ICH/GCP guidelines, regulatory requirements, and established budget and timelines. Reporting to the VP, Clinical Development and Operations, this position plays a critical role in vendor management, financial stewardship, and the delivery of high-quality, efficient clinical trials.
Key Responsibilities and Duties
Responsibilities will include, but not limited to:
  • Develop, manage, and track site and study budgets in collaboration with CROs and internal Finance partners.
  • Review, reconcile, and approve vendor and CRO invoices against contracts, milestones, and deliverables.
  • Support clinical operations contracting processes, including review of scopes of work, vendor agreements, and amendments.
  • Manage and review change orders, ensuring alignment with scope, timelines, and budget.
  • Generate and maintain purchase orders (POs) in accordance with company processes and study budgets.
  • Support vendor selection, onboarding, and ongoing performance management to ensure adherence to KPIs and contractual commitments.
  • Support oversight of CROs to ensure clinical trials are executed according to timelines, quality standards, and contractual obligations.
  • Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and continuous inspection readiness. Monitor TMF completion metrics to ensure timely and comprehensive document completeness.
  • Collaborate closely with cross-functional teams including Finance, Legal, CMC, Pre-clinical to ensure seamless execution of clinical programs.
  • Proactively identify risks in study execution and financial management, and implement mitigation strategies.
  • Support onboarding procedure and training on internal processes for new team members.

Other Responsibilities
  • Adhere to the Company's quality management system processes and policies.
  • Comply with applicable regulatory requirements, policies, and procedures related to financial reporting transparency, Good Clinical Practice (GCP), and Good Documentation Practice (GDP).
  • Other tasks as requested by the VP Clinical Development and Operations.

Essential Skills, Qualifications, Industry and Educational Requirements
  • Strong knowledge of clinical trial conduct, ICH-GCP guidelines, regulatory requirements, and the Sunshine Act.
  • Meticulous attention to detail to ensure accuracy in documentation and financial tracking.
  • Demonstrated ability to manage budgets, forecasting, and financial reconciliation.
  • Flexibility to collaborate across different time zones
  • Experience with TMF processes and inspection readiness standards.
  • Ability to work to timelines and perform effectively in high-pressure environments.
  • Strong organizational, analytical, and problem-solving skills.

Desirable Skills, Qualifications, Industry and Educational Requirements
  • Proven track record in clinical operations delivery within a sponsor or CRO environment.
  • Demonstrated expertise in vendor management, CRO oversight, and contract management.
  • Experience with budgeting tools, CTMS, and eTMF systems.
  • Strong communication and collaboration skills across cross-functional teams.
  • Minimum 6-10 years' experience in clinical operations (depending on level).
  • Bachelor's degree in life sciences required; advanced degree (MSc or higher) preferred.

$123,000 - $154,000 a year