ZipRecruiter

Log In

1

Trial Master File Associate Jobs in Watchung, NJ

IQVIA

Clinical Research Associate

Parsippany, NJ · On-site

$71K - $189K/yr

Clinical Research Associate II & Senior Clinical Research Associate (CRA II/Sr. CRA) Multiple ... Trial Master File (TMF) and Investigator Site File (ISF). * Prepare comprehensive monitoring ...

IQVIA

Clinical Research Associate

Parsippany, NJ

$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 ...

previous pagenext page

Showing results 21-40

All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Watchung, NJ

Trial Master File Associate information

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.

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

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 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 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 cities near Watchung, NJ are hiring for Trial Master File Associate jobs?

Cities near Watchung, NJ with the most Trial Master File Associate job openings:

Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Watchung, NJ as of August 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 67% In-person, and 33% Remote job distribution.

Senior Director, TMF Services

Transperfect Gaming Solutions

Princeton, NJ • On-site, Remote

Full-time

Re-posted 27 days ago

Job description

Who We Are:
TransPerfect is the world's largest provider of language services and technology solutions for global business. From offices in over 160 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.
Summary:
The Senior Director, TMF Services is a senior leadership role responsible for the end-to-end management and strategic direction of the TMF Services division, overseeing service delivery, operational growth, and the continuous expansion of service offerings. The Senior Director will lead the strategic growth, operational excellence, and delivery of LMK's Trial Master File (TMF) services while building strong relationships across LMK, TransPerfect, and its global client base. Serving as a visible market presence and internal champion, this role drives operational excellence, AI-enabled productivity, and client success across the division. The Senior Director works cross-functionally with internal stakeholders and external clients to ensure the highest standards of delivery while positioning the LMK's TMF Services division for sustained commercial growth.
TransPerfect Life Sciences is a leading provider of services and technologies supporting global clinical trials and product development for the biopharmaceutical industry. As part of the TransPerfect family of companies, LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions. Together, TransPerfect and LMK deliver comprehensive, system-agnostic TMF consulting, document management, quality control, and inspection readiness services to sponsors of all sizes. By combining decades of expertise in TMF best practices, innovation, and clinical operations, TransPerfect and LMK help clients optimize TMF processes, maintain regulatory compliance, and accelerate clinical research with confidence.
What You Will Be Doing:
  • Partner with executive leadership to develop annual business plans, revenue targets, and service line roadmap.
  • Support business development to identify, pursue, and close new business opportunities including new client relationships, expanded scopes of work, and strategic partnerships.
  • Own Profit & Loss (P&L) accountability for the divisions TMF Services practice, driving profitability through efficient delivery models and pricing strategy.
  • Continuously evaluate and implement best-in-class tools and workflows for eTMF management, TMF record quality, and inspection readiness.
  • Establish scalable delivery frameworks and quality standards across client engagements.
  • Monitor industry trends (regulatory guidance, technology evolution, competitive landscape) and translate insights into service improvements.
  • Revise, implement and monitor departmental compliance with SOPs.
  • Champion the adoption of AI technologies, automation, and digital tools to enhance team productivity and client outcomes.
  • Serve as an executive sponsor for key client accounts, ensuring high levels of satisfaction, retention, and growth.
  • Oversee the successful delivery of the TMF Services portfolio, ensuring projects meet quality, timeline, budget, and compliance objectives.
  • Build trusted advisor relationships with client stakeholders at the director and C-suite level.
  • Ensure team members meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.
  • Serve as a visible spokesperson and subject matter expert for the company in the eTMF and clinical operations space.
  • Represent the organization as a thought leader and subject matter expert through industry conferences, publications, webinars, and professional networks.
  • Build and maintain a strong external network with sponsors, CROs, technology vendors, and industry associations.
  • Recruit, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement.
  • Collaborate cross-functionally with commercial, technology, and operational teams to achieve strategic business objectives.
  • Complete all other tasks deemed appropriate for the role as assigned by the manager/supervisor.
Who We Are Looking For:
  • Minimum Bachelor's degree or equivalent in life sciences, health sciences, or related field.
  • At least 12 years of progressive experience in clinical operations, TMF, or clinical records management within a CRO, sponsor company, or clinical services provider.
  • Minimum of 10 years of supervisory/management experience.
  • Strong understanding of clinical trial processes and clinical records management operations.
  • Proven experience presenting, speaking, or publishing in industry forums and professional settings.
  • Demonstrated success in leading and scaling teams in fast-paced, client-facing environments.
  • Demonstrated expertise in Trial Master File (TMF) strategy, eTMF platforms (e.g., Veeva Vault, TI, Wingspan, Medidata etc.), and supporting TMF inspection readiness.
  • Strong knowledge of applicable regulations and guidance: ICH E6(R2/R3), FDA 21 CFR Part 11, EMA TMF guidelines, CDISC TMF Reference Model.
  • Strong understanding of drug development and clinical trials operations.
  • Proven ability to navigate ambiguity and successfully build and scale processes, teams, and service offerings.
  • Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint). Outstanding verbal and written and interpersonal communication skills, with strong active listening abilities.
  • Strong analytical, problem-solving, and critical-thinking skills.
  • Ability to work effectively in a global, cross-functional environment with internal and external stakeholders.
  • Willingness to travel as required.

DESIRED BUSINESS SKILLS AND EXPERIENCE
  • Proven track record of business development and/or account growth in a services environment.
  • Active involvement in industry organizations (CDISC TMF Reference Model, etc.).
  • Experience evaluating and implementing AI/ML tools or automation within clinical workflows.
  • Prior P&L ownership or practice management experience within a boutique or mid-size services organization.

Where Your Career Is Going:
At TransPerfect, there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills, interest, and experience. We encourage our employees to have a continuous dialogue with management about growth opportunities throughout your tenure with the company.
End your job search and find your career at TransPerfect #careersNOTjobs.
Why TransPerfect:
For more than 30 years, TransPerfect has honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.

Apply