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Tmf Support Analyst Jobs (NOW HIRING)

Ocugen Inc

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

... cause analysis and implement corrective and preventive actions (CAPAs). * Maintain ongoing ... Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including ...

OCUGEN OPCO INC

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

... cause analysis and implement corrective and preventive actions (CAPAs). * Maintain ongoing ... Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including ...

Ocugen Opco Inc

TMF Lead

Malvern, AR · On-site

$150 - $200/hr

... analysis and implement corrective and preventive actions (CAPAs).Maintain ongoing inspection ... Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including ...

TMF Group

Analyst, Capital Markets

New York, NY · On-site

... through TMF Group's teams in 120 offices. Discover the Role We're looking for an analyst for capital markets, for our New York Office! Key Responsibilities Support Treasury function, including:

BridgeBio Pharma

Associate Director, TMF Operations Lead

$34.25 - $46.75/hr

... audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up. * ... Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process ...

BridgeBio Pharma

Associate Director, TMF Operations Lead

$34.25 - $46.75/hr

... audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up. * ... Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process ...

TMF Group

Senior Executive

Continuous development is supported through global learning opportunities from the TMF Business Academy Making an impact * You'll be helping us to make the world a simpler place to do business for ...

Aditum Bio

Senior Clinical Trial Manager

Cambridge, MA · On-site

... ready TMF. * Support clinical trial audits and inspections. * Participate in review of patient ... Strong organizational, project management, analytical, and problem-solving skills with exceptional ...

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Tmf Support Analyst information

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How much do tmf support analyst jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for tmf support analyst in the United States is $39.80, according to ZipRecruiter salary data. Most workers in this role earn between $31.49 and $45.67 per hour, depending on experience, location, and employer.

What is a TMF Support Analyst?

A TMF Support Analyst is a professional who manages and maintains the Trial Master File (TMF) in clinical research settings. Their main responsibilities include ensuring the completeness, accuracy, and regulatory compliance of clinical trial documentation. TMF Support Analysts work closely with clinical teams to organize, review, and audit essential documents, helping to ensure smooth clinical trial operations and successful regulatory submissions. They also troubleshoot TMF-related issues and provide guidance on best practices for document management.

What are the key skills and qualifications needed to thrive as a TMF Support Analyst?

To thrive as a TMF Support Analyst, you need a solid understanding of Trial Master File (TMF) processes, clinical documentation standards, and regulatory compliance, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management tools, and knowledge of ICH-GCP guidelines are typically required. Attention to detail, strong organizational skills, and effective communication are vital soft skills in this role. These competencies ensure accurate document management, regulatory readiness, and smooth collaboration within clinical research teams.

How does a TMF Support Analyst typically collaborate with clinical trial teams to ensure timely document management?

A TMF Support Analyst works closely with clinical trial teams, including clinical operations, regulatory affairs, and quality assurance, to ensure that essential trial documents are accurately uploaded, tracked, and maintained within the Trial Master File (TMF) system. They facilitate regular communication with study teams to clarify documentation requirements, resolve discrepancies, and support audit readiness. This collaborative approach helps maintain compliance with regulatory standards and ensures that all documentation is up-to-date throughout the study lifecycle.

What is the difference between Tmf Support Analyst vs Tmf Business Analyst?

AspectTmf Support AnalystTmf Business Analyst
Primary RoleProvides technical support and troubleshooting for Tmf systemsAnalyzes business needs and recommends system improvements
Required SkillsTechnical knowledge of Tmf platforms, problem-solvingBusiness process understanding, communication skills
CertificationsIT support or Tmf-specific certifications often preferredBusiness analysis certifications like CBAP may be advantageous
Work EnvironmentIT support teams, technical departmentsBusiness units, project teams

The Tmf Support Analyst primarily focuses on technical support and issue resolution within Tmf systems, while the Tmf Business Analyst concentrates on understanding business needs and implementing system solutions. Both roles require familiarity with Tmf platforms but serve different functions in the organization.

What states have the most Tmf Support Analyst jobs?

States with the most job openings for Tmf Support Analyst jobs include:

What are popular job titles related to Tmf Support Analyst jobs?

For Tmf Support Analyst jobs, the most frequently searched job titles are:

Infographic showing various Tmf Support Analyst job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution, with an average salary of $82,791 per year, or $39.8 per hour.

TMF Lead

Malvern, PA • On-site

Ocugen Inc
Biotechnology Research and Development • 51 - 200 employees
Learn more about Ocugen Incexternal

$32.75 - $45/hr

Other

Re-posted 4 days ago

Job description

Position Summary
The TMF Lead is an independently resourceful subject matter expert (SME) responsible for the quality, completeness, and inspection readiness of Trial Master Files (TMFs) across assigned clinical studies, from study startup through study closeout and archive, within the Veeva TMF (Vault) system. Operating in a small biotech environment with competing priorities, the TMF Lead works with minimal oversight, serving as the primary go-to resource for all TMF-related questions and driving TMF operational excellence in close collaboration with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, Quality Assurance, and external CROs/vendors, in adherence to company SOPs, ICH-GCP, and applicable regulatory requirements.
Responsibilities
  • Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase of the trial, within the Veeva TMF (Vault) platform.
  • Serve as the primary TMF subject matter expert (SME) and go-to resource for study teams, Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, and external CROs/vendors on all TMF-related questions, processes, and requirements.
  • Develop and maintain TMF management plans, filing strategies, and Expected Document List (EDL) configurations aligned to the DIA TMF Reference Model; review and monitor TMF metrics, KPIs, and quality indicators; perform routine TMF health checks and reconciliation activities.
  • Conduct TMF Quality Control (QC) reviews and periodic self-inspections; identify TMF risks, gaps, and misfiled or missing documents; drive root-cause analysis and implement corrective and preventive actions (CAPAs).
  • Maintain ongoing inspection readiness for all assigned studies; coordinate document retrieval and responses during sponsor audits and regulatory inspections (FDA, EMA, MHRA, and other health authorities); lead TMF remediation activities and inspection preparation exercises.
  • Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle.
  • Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system upgrades, migrations, or implementation projects.
  • Partner with Clinical Operations, CRAs, and CRO/vendor TMF counterparts to ensure timely, accurate transfer and filing of site, vendor, and trial-level documents; reconcile CRO-held TMF content against the Expected Document List and the company TMF.
  • Provide TMF training, guidance, and just-in-time coaching to study teams, new hires, and cross-functional stakeholders; facilitate study team meetings focused on TMF compliance and document management.
  • Track and report TMF workload, completeness, and quality metrics to management; proactively identify and escalate TMF risks and resourcing constraints, particularly given competing study priorities typical of a small biotech.
  • Contribute to the authorship and continuous improvement of TMF-related SOPs, work instructions, and job aids; drive adoption of TMF best practices across the organization.
  • Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including participation in TMF-focused RFI/RFP activities and vendor eTMF interoperability assessments.
  • Independently prioritize and manage TMF deliverables across multiple concurrent studies with minimal supervision, exercising sound judgment in a resource-constrained, fast-paced small-biotech environment.
  • Additional tasks and projects as requested.

  • Bachelor's degree in life sciences or a related field; advanced degree a plus.
  • 5-7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management.
  • Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required).
  • Working knowledge of the DIA TMF Reference Model (TMF RM) and Expected Document List (EDL) management.
  • Strong knowledge of ICH-GCP, FDA, EMA, MHRA, and other applicable global regulatory requirements governing TMF content and inspection readiness.
  • Demonstrated experience supporting sponsor audits and/or regulatory inspections, including TMF remediation.
  • CRO/vendor management experience, including oversight of TMF-related deliverables.
  • Experience in Ophthalmology and/or advanced (cell and gene) therapy studies in Phases 1-3 preferred.
  • Experience with CTMS, EDC, and RTSM a plus.
  • Demonstrated ability to work independently and resourcefully in a small biotech with competing priorities and limited resources.
  • Excellent cross-functional communication and collaboration skills; proven ability to serve as an SME and trusted go-to resource.
  • Outstanding attention to detail, organizational skills, and document/records management discipline.
  • Self-motivated with a strong commitment to quality, accuracy, and on-time deliverables.
  • Demonstrated ability to identify, escalate, and resolve issues, and to manage competing timelines
  • Critical skills and competencies
  • Veeva Vault eTMF platform expertise, including configuration, user/role administration, workflow, and metadata management (required, not just end-user experience).
  • Deep, practical knowledge of TMF content requirements across the full trial lifecycle: study startup, conduct, closeout, and archive.
  • TMF quality-control, completeness, and inspection-readiness methodology, including DIA TMF Reference Model application and Expected Document List reconciliation.
  • Regulatory inspection support experience (FDA/EMA/MHRA), including document retrieval and inspection-room readiness.
  • Risk-based thinking: proactive identification of TMF gaps and risks, with sound CAPA development and follow-through.
  • Cross-functional influence without direct authority - able to hold Clinical Operations, Data Management, Regulatory, Biostatistics, Pharmacovigilance, and CRO/vendor partners accountable to TMF timelines and quality standards.
  • Independent judgment and prioritization in a small-biotech, resource-constrained, multi-study environment with competing priorities.
  • SOP authorship and continuous-process-improvement mindset.
  • Training and mentoring skills - able to onboard and train study teams and new hires on TMF processes and expectations.
  • Strong digital literacy across eTMF, CTMS, EDC, and RTSM systems, with the ability to troubleshoot system and process issues.

Working Conditions
This position operates in an office setting and may include up to 10% travel to visit sites, vendors, or CROs, as applicable. This role may require the incumbent to be available outside standard hours to handle priority business needs, consistent with the demands of a small biotech.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
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About Ocugen

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Malvern, PA, US

Year founded

2013

Social media

Twitter

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