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

Clinovo

Clinical Trial Manager

Cambridge, MA · On-site

$175K/yr

Maintain complete, accurate, and inspection-ready Trial Master File (TMF) documentation. Study Closeout Activities * Coordinate site closure activities, reconciliation processes, and final study ...

Skyhawk Therapeutics

Clinical Trial Manager

Waltham, MA · 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 ...

Skyhawk Therapeutics

Clinical Trial Manager

Waltham, MA · 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 ...

Verastem Oncology

Clinical Trial Manager

Boston, MA · On-site

$100 - $125/hr

Assume responsibility for setting up trial master file and ensuring the trial(s) is "audit ready" at all times. * Review, complete and ensure implementation of corrective action plans in conjunction ...

Verastem

Clinical Trial Manager

Boston, MA · On-site

$100K - $125K/yr

Assume responsibility for setting up trial master file and ensuring the trial(s) is "audit ready" at all times. * Review, complete and ensure implementation of corrective action plans in conjunction ...

eGenesis

Senior Clinical Trial Manager

Cambridge, MA · On-site

$142K - $176K/yr

Serve as a point of contact for CRO and clinical site communication * Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic ...

eGenesis

Senior Clinical Trial Manager

Cambridge, MA

$142K - $176K/yr

Serve as a point of contact for CRO and clinical site communication * Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic ...

eGenesis

Senior Clinical Trial Manager

Cambridge, MA · On-site

$142K - $176K/yr

Serve as a point of contact for CRO and clinical site communication * Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic ...

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 ...

Dyne Therapeutics

Senior Clinical Trial Associate

Waltham, MA · On-site

$36.25 - $49.25/hr

Collect, file, reconcile, and track essential documents for the trial master file (TMF); conduct routine TMF reviews, identify gaps, follow up on missing documentation, and support ongoing inspection ...

Ipsen

Clinical Trial Administrator

Cambridge, MA · On-site

$80 - $100/hr

Set-up, monitoring, verifying and archiving the clinical Trial Master File (TMF):*** In charge of the Ipsen TMF (electronic and/or paper, if applicable) set-up and administration.* Manage the ...

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Showing results 21-40

All JobsTrial Master File Job JobsTrial Master File Job Jobs in Boston, MA

Trial Master File Job information

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

AspectTrial Master File JobClinical Document Coordinator
Required CredentialsTypically a degree in life sciences or related field, with experience in clinical trialsOften a degree in health sciences, nursing, or related field, with document management experience
Work EnvironmentPharmaceutical or CRO settings, managing trial documentationClinical sites or research organizations, coordinating document flow
Employer & Industry UsageUsed in clinical research, pharmaceutical, biotech industriesCommon in clinical research sites, hospitals, and research organizations

The Trial Master File Job focuses on managing and maintaining essential trial documentation for regulatory compliance, often within pharmaceutical or CRO settings. The Clinical Document Coordinator handles clinical documents at research sites or hospitals, ensuring proper documentation flow. While both roles involve document management in clinical research, the Trial Master File Job is more specialized in regulatory filing and trial oversight, whereas the Clinical Document Coordinator emphasizes site-level documentation coordination.

What are popular job titles related to Trial Master File Job jobs in Boston, MA?

For Trial Master File Job jobs in Boston, MA, the most frequently searched job titles are:

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Trial Master File Job jobs near you

Associate Director, Trial Operations & Budget

AdvanCell

Boston, MA • On-site

$123K - $154K/yr

Full-time

Re-posted 8 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

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