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Tmf Jobs in California (NOW HIRING)

Integrated Resources INC

Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for Gilead ...

ICON

Clinical Trial Assistant

San Francisco, CA · On-site

$56K - $70K/yr

Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan. Help draft TMF plan * Facilitate ...

Icon plc

Clinical Trial Assistant

San Francisco, CA · Hybrid

$56K - $70K/yr

Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan. Help draft TMF plan * Facilitate ...

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How much do tmf jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for tmf in California is $39.46, according to ZipRecruiter salary data. Most workers in this role earn between $31.78 and $43.41 per hour, depending on experience, location, and employer.

What is a TMF?

A TMF (Trial Master File) job typically involves managing and maintaining essential documents related to clinical trials. Professionals in this role ensure that all trial documentation complies with regulatory requirements and is audit-ready. They may work with electronic TMF (eTMF) systems, collaborate with study teams, and ensure document accuracy and completeness. TMF specialists play a crucial role in supporting clinical research compliance and regulatory submissions.

What are the main responsibilities of a TMF specialist on a daily basis?

As a TMF Specialist, your daily responsibilities include maintaining and updating essential clinical trial documents, ensuring accurate filing and compliance with regulatory standards, and performing routine quality checks on documentation. You will collaborate closely with clinical operations, project managers, and external stakeholders to gather and validate needed materials. Attention to deadlines and meticulous organization are critical, as audits and inspections may require quick access to correctly archived files. This hands-on role is vital for ensuring that all documentation is complete, accurate, and ready for review throughout the life cycle of a clinical trial.

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

To thrive as a TMF (Trial Master File) Specialist, you need a solid understanding of clinical trial documentation, regulatory guidelines (such as ICH-GCP), and strong organizational skills, typically supported by experience in clinical research or a related life sciences field. Proficiency with electronic Trial Master File (eTMF) systems, document management software, and sometimes certifications like DIA TMF or clinical research certification are commonly required. Attention to detail, effective communication, and the ability to manage deadlines are important soft skills in this role. These competencies ensure regulatory compliance, efficient document retrieval, and successful clinical trial audits.

What are the most commonly searched types of Tmf jobs in California?

The most popular types of Tmf jobs in California are:

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For Tmf jobs in California, the most frequently searched job titles are:

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Tmf jobs near you
Infographic showing various Tmf job openings in California as of August 2026, with employment types broken down into 96% Full Time, and 4% Contract. Highlights an 63% Physical, 8% Hybrid, and 29% Remote job distribution, with an average salary of $82,080 per year, or $39.5 per hour.

Document and Clinical Systems Manager (TMF)

Neurocrine Biosciences, Inc.

San Diego, CA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 4 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 strategic support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). Serves as subject matter expert for Clinical information systems, including a Clinical Trial Management System (CTMS), 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):
  • Support in development of strategic direction of clinical system(s) functionality to align with business demands and industry best practices
  • Participate in development and presentation of business cases to support approval for clinical system(s) implementation
  • Provides compliance guidance for the setup, maintenance and reporting from one or more clinical system(s)
  • Plan/assist the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards in collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders
  • Creates the documentation of 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
  • Serves as subject matter expert 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
  • Lead monthly eTMF meetings for internal CO Study Team
  • Manages the Clinical System, including managing user access, user training, and system releases
  • Act as lead Clinical System Admin (add organization, user help, troubleshoot errors, etc.)
  • Generate and send out monthly dashboards and reports
  • Evaluates key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections
  • Proactively 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
  • Creates TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival
  • 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
  • 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 necessary and assigned by management

Requirements:
  • BS/BA degree in life science or related field or RN AND 6+ years working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO. Additional years of experience in lieu of educational requirement may be considered. OR
  • Master's degree life science or related field AND 4+ years of experience as noted above
  • Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
  • Works to improve tools and processes within functional area
  • Developing reputation inside the company as it relates to area of expertise
  • Ability to work as part of and lead multiple teams
  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
  • Excellent computer skills
  • Excellent communications, problem-solving, analytical thinking skills
  • Sees broader picture, impact on multiple departments/divisions
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
  • Excellent project management skills
  • 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 $130,800.00-$179,000.00. 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 30% 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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