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Trial Master File Jobs in Edison, NJ (NOW HIRING)

IQVIA

CRA 2, Oncology, IQVIA

Parsippany, NJ · On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

Parsippany, NJ · On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Icon plc

Clinical Study Specialist

Warren, NJ · Hybrid

$62K - $77K/yr

Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance * Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

New

IQVIA

Clinical Research Associate

Parsippany, NJ · On-site

$87K - $182K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

Clinical Research Associate

Parsippany, NJ

$71K - $189K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

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Trial Master File information

What are the key skills and qualifications needed to thrive in the trial master file position, and why are they important?

To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.

What is a trial master file?

A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.

What are the typical responsibilities and daily tasks of a trial master file specialist?

As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

What are popular job titles related to Trial Master File jobs in Edison, NJ? For Trial Master File jobs in Edison, NJ, the most frequently searched job titles are:
What job categories do people searching Trial Master File jobs in Edison, NJ look for? The top searched job categories for Trial Master File jobs in Edison, NJ are:
What cities near Edison, NJ are hiring for Trial Master File jobs? Cities near Edison, NJ with the most Trial Master File job openings:
Trial Master File jobs near you
Infographic showing various Trial Master File job openings in Edison, NJ as of August 2026, with employment types broken down into 100% Full Time. Highlights an 81% In-person, 5% Hybrid, and 14% Remote job distribution.

Clinical Study Manager, Global Clinical Operations

Daiichi Sankyo, Inc.

Basking Ridge, NJ • On-site

Full-time

Re-posted 28 days ago

Job description

Clinical Study Manager, Global Clinical Operations
Job Requisition ID: 1722
Posting Start Date: 6/29/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role is primarily focused on tactical study delivery and reports to a Director or higher-level position. The position requires excellent written and verbal communication, project management skills, and attention to detail. The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries. This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution.
Job Description
Responsibilities
Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables. In a CRO outsourcing model, responsibilities also include:
  • Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. May provide support as back-up to the Study Delivery Lead as needed.
  • Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Provide mentorship of more junior Operations team members.
  • Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget. Oversee complex vendors (i.e., eCOA).
  • CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings.
  • Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
  • Timeline and Budget Management: Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets. Responsible for continual review of study timelines and study budget.
  • Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle. Ensure risks are appropriately logged in the risk management system.
  • Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure all necessary operational materials are in place.
  • Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.
  • Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial.
  • Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead.
  • Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).).
    o Supports risk Management initiatives
    o Supports audit/inspection activities as needed
    o Ensures trial master file is complete and accurate for assigned stud(ies)
  • Communication and Reporting: Provide regular updates on study progress to key stakeholders.
  • Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. Develop training materials as necessary.

Responsibilities Continued
Qualifications
Education Qualifications
Bachelor's Degree preferred in Life Sciences required
Experience Qualifications
3 or more years required and
Relevant experience is required with a BSc required and
Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
CRA experience preferred
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred
Familiarity to a Japan-based organization preferred
Travel Requirements
Ability to travel up to 10% of the time. In-house office position that may require occasional travel (domestic or global).
Additional Information
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$136,080.00 - USD$204,120.00
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