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Trial Master File Associate Jobs in California (NOW HIRING)

Solomon Page

Sr CTA - Autoimmune

San Diego, CA · On-site

$35 - $48/hr

The Senior Clinical Trial Associate supports the operational execution of clinical studies by ... Maintain and organize Trial Master File (TMF) documentation and track essential study records.

Janux Therapeutics

Sr. Clinical Trial Manager

San Diego, CA · On-site

$175K - $200K/yr

The Associate Director, Clinical Operations will be responsible for managing operational aspects of ... Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF)

Abbott

Clinical Research Associate II

Alameda, CA · On-site

$81K - $141K/yr

As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...

Abbott

Clinical Research Associate II

Alameda, CA · On-site

$81K - $141K/yr

As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...

Abbott

Clinical Research Associate II

Alameda, CA · On-site

$81K - $141K/yr

As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...

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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 are the most commonly searched types of Trial Master File jobs in California?

The most popular types of Trial Master File jobs in California are:

What are popular job titles related to Trial Master File Associate jobs in California?

For Trial Master File Associate jobs in California, the most frequently searched job titles are:

What job categories do people searching Trial Master File Associate jobs in California look for?

The top searched job categories for Trial Master File Associate jobs in California are:

What cities in California are hiring for Trial Master File Associate jobs?

Cities in California with the most Trial Master File Associate job openings:

Trial Master File Associate jobs near you

Global Clinical Trial Leader

South San Francisco, CA

CYNET SYSTEMS
IT Services • 501 - 1,000 employees
Learn more about CYNET SYSTEMSexternal

$100 - $105/hr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 5 days ago

Job description

Job Overview:

Pay Range: $100.07hr - $105.07hr

Requirement/Must Have:

  • 8+ years of clinical study management experience desired.
  • Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process.
  • Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
  • Demonstrated success effectively managing a diverse portfolio of vendors and CROs.
  • Adept at identifying, assessing, and proactively mitigating operational risks using quantitative and qualitative data.
  • Some travel may be required.

Responsibilities:

  • Accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL.
  • Implement novel and highly flexible global operational strategies for complex programs focusing on new molecular entities.
  • Provide operational guidance to one or more global cross-functional Protocol Execution Teams (PETs) across all study stages including start-up, conduct, and close-out.
  • Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
  • Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
  • Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.
  • Participate in vendor selection and oversee outsourced activities to ensure CROs and vendors deliver strictly against contracted scopes of work.
  • Provide strategic input into the overall study budget and directly manage assigned vendor budgets.
  • Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
  • Apply critical thinking to manage timelines, identify bottlenecks, and propose actionable resolutions.
  • Maintain a patient and site-centric mindset across all trial activities and interactions.
  • Partner with colleagues to establish operational best practices and enhance clinical trial execution across the organization.
  • Serve as a Subject Matter Expert (SME) or single point of contact for targeted functional initiatives.
  • Coach, mentor, and share expertise to support the development of junior staff and peers.

Skills:

  • GCP/ICH requirements.
  • Clinical study management.
  • Vendor management.
  • Risk mitigation.
  • Drug supply forecasting.
  • Trial Master Files (TMF).
  • CTMS data.
  • Protocol feasibility.
  • Strong verbal and written communication skills.
  • Excellent communication and presentation skills.
  • Problem solving.
  • Stakeholder management.

Qualification And Education:

  • Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).

Benefits:

Our Benefits Include:

  • Medical, Dental, and Vision Insurance
  • 401(k) Retirement Plan
  • Health Savings Account (HSA)
  • Disability Insurance (Short-Term and Long-Term)
  • Life and AD&D Insurance
  • Paid Sick Leave (where required by applicable state or local law)
  • Supplemental Insurance Plans
  • Identity Theft Protection
  • Pet Insurance
  • Employee Wellness Programs
  • Employee Assistance Program (EAP)
  • Career Growth and Professional Development Opportunities

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.


About Cynet Systems


Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

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About Cynet Systems

Sourced by ZipRecruiter

Cynet Systems Inc is a staffing and recruiting corporation nestled in Ashburn, VA, USA. Established in 2010, the company operates within the Information Technology and Services sector, specializing in providing effective workforce solutions to different business needs, including IT consulting, direct hire, and contract staffing services. Through the years, Cynet Systems has built an impressive portfolio, going beyond borders and expanding its operations internationally in Canada and India. Rooted in its core values of teamwork, leadership, and commitment, Cynet Systems helps businesses unlock their full potential by providing versatile and competent professionals that perfectly align with their needs. Fueled by their unwavering mission to deliver top-tier talent to businesses worldwide, Cynet Systems garnered various recognitions including SIA's fastest-growing staffing firms and Best Place to Work in Virginia for 2019.

Industry

It services

Company size

501 - 1,000 Employees

Headquarters location

Sterling, VA, US

Year founded

2010

Social media

Twitter

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