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Tmf Manager Jobs (NOW HIRING)

Praxis Precision Medicines, Inc.

TMF Operations Lead

$95K - $118K/yr

Qualifications and Key Success Factors * 5+ years of TMF management experience and a bachelor's degree. * Deep knowledge of ICH/GCP, FDA, and international TMF requirements. * Strong experience with ...

BeiGene

Manager, TMF Systems

Manhattan, NY · On-site

$124K - $164K/yr

General Description Work with supervisor to execute multiple, highly complex TMF processes in relation to the global eTMF system and Global TMF roadmap. Manage validation of the eTMF system for ...

Systimmune

Associate Director, TMF Operations

Princeton, NJ · On-site

$140K - $180K/yr

Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs ... The role involves collaborating with senior leaders and key stakeholders to establish, manage, and ...

Systimmune

Associate Director, TMF Operations

Princeton, NJ · On-site

$140K - $180K/yr

Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs ... The role involves collaborating with senior leaders and key stakeholders to establish, manage, and ...

BeiGene, Inc.

Manager, TMF Systems

$124K - $164K/yr

Work with supervisor to execute multiple, highly complex TMF processes in relation to the global eTMF system and Global TMF roadmap. * Manage validation of the eTMF system for change controls, data ...

Vericel Corporation

TMF Specialist

Burlington, MA · On-site

$75K - $90K/yr

Position Summary The TMF specialist is responsible for the end-to-end management, quality, and integrity of clinical trial documentation. This role ensures a "continuous state of readiness" for ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

TMF Group

Client Director

Manhattan, NY · On-site

Manage executive-level escalations and ensure timely resolution in coordination with TMF escalation points. * Establish and maintain a clear communication and governance model, including regular ...

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How much do tmf manager jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for tmf manager in the United States is $62.52, according to ZipRecruiter salary data. Most workers in this role earn between $50.72 and $70.43 per hour, depending on experience, location, and employer.

What are some typical challenges a TMF Manager might face in their role?

TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.

What are the key skills and qualifications needed to thrive in the Tmf Manager position, and why are they important?

To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.

What is a TMF Manager job?

A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.

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Tmf Manager jobs near you
Infographic showing various Tmf Manager job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $130,034 per year, or $62.5 per hour.
Specialist, Document & Clinical Systems (TMF)

Specialist, Document & Clinical Systems (TMF)

Neurocrine Biosciences, Inc.

San Diego, CA • On-site

$37 - $49.75/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 18 days ago

Job description

Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
About the Role:
Provides support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). May serve as subject matter expert for electronic TMF (eTMF) end-users, and facilitates responses to audits/inspections. Collaborates closely with the Clinical Operations Study Team Members and Functional Groups as TMF System Owner.
Your Contributions (include, but are not limited to):
  • In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders to assist in the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards
  • Assist with documenting the set-up, review, maintenance and archival of study specific TMFs in TMF Plans and study specific TMF Index. Plans may include TMF transition and/or migration activities
  • Provides guidance for the eTMF, providing technical expertise and advice to end-users and all stakeholders
  • Takes a proactive role in providing a high level of service to eTMF end-users.
  • Provides informal review of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections
  • Informs CO Study Team Leaders and Upper Managers of deficiencies from informal reviews
  • Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required
  • Participates in quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
  • Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
  • Participates in CO Study Team meetings and eTMF QC meetings, as requested
  • Reviews and provides input in TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival
  • Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development
  • Perform other duties as as assigned

Requirements:
  • BS/BA degree in life science or related field or RN AND 2+ years working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO OR
  • Master's degree life science or related field AND some related experience as noted above
  • Understands Neurocrine's business objectives and develops understanding of Neurocrine's services and customers
  • Has experience in specific functional discipline while working to acquire higher-level knowledge and skills
  • Comfortable with tools and processes that support work conducted by functional area
  • Ability to work as part of a team
  • Strong computer skills
  • Good interpersonal, organizational, communications, problem-solving, analytical thinking skills
  • Detail oriented
  • Ability to meet deadlines
  • Good project management skills
  • Demonstrates technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Constantly maintains knowledge in an on-going manner
  • Able to work independently and to function as a team player
  • Able to manage/prioritize own work
  • Knowledge of FDA regulations, Good Clinical Practices (GCPs), and ICH Guidelines necessary
  • Working knowledge of clinical study documents and managing Trial Master Files in Clinical Systems (eTMF and CTMS - Veeva preferred)
  • Ability to process, archive, and retrieve documents in electronic format
  • Working knowledge of clinical trials is required
  • Computer proficiency with MS Office

#LI-RS1
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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