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Director Trial Master File Jobs (NOW HIRING)

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is ...

Crinetics Pharmaceuticals

Clinical Trial Associate

$34.25 - $46.75/hr

Maintain the Trial Master File for all clinical projects * Perform periodic reviews and QC of the Trial Master File * Travel as required to carry out responsibilities * Other duties as assigned ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

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Director Trial Master File information

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$45K

$128.4K

$232.5K

How much do director trial master file jobs pay per year?

As of May 31, 2026, the average yearly pay for director trial master file in the United States is $128,367.00, according to ZipRecruiter salary data. Most workers in this role earn between $58,000.00 and $188,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director Trial Master File, and why are they important?

To thrive as a Director Trial Master File, you need deep knowledge of clinical trial processes, regulatory guidelines (such as GCP and ICH), and extensive experience in TMF management, often supported by a relevant degree and prior leadership in clinical operations. Expertise with electronic Trial Master File (eTMF) systems, document management platforms, and familiarity with industry certifications like DIA TMF Practitioner are highly valued. Strong leadership, attention to detail, and excellent communication skills distinguish top performers in this role. These capabilities ensure regulatory compliance, audit readiness, and effective oversight of clinical trial documentation, which are critical for successful drug development.

What are some common challenges a Director of Trial Master File faces when ensuring TMF completeness and inspection readiness?

A Director of Trial Master File often encounters challenges related to maintaining TMF completeness across multiple studies and vendors, ensuring timely document submission, and preparing for regulatory inspections. Coordinating efforts among cross-functional teams—including clinical operations, regulatory affairs, and external partners—can be complex, especially when aligning on documentation standards and resolving discrepancies. Proactive communication, robust quality control processes, and familiarity with evolving regulatory requirements are key to overcoming these challenges and ensuring inspection readiness.

What are Director Trial Master File roles and responsibilities?

A Director of Trial Master File (TMF) oversees the management and quality of TMF systems, which are essential for documenting the conduct of clinical trials. They ensure that all trial documentation is complete, accurate, and compliant with regulatory requirements. This role involves developing TMF strategies, leading teams, implementing best practices, and collaborating with clinical, regulatory, and quality assurance departments to support clinical trial audits and inspections. The director also manages TMF vendors, monitors key performance indicators, and drives process improvements.

What is the difference between Director Trial Master File vs Clinical Trial Coordinator?

AspectDirector Trial Master FileClinical Trial Coordinator
CredentialsAdvanced degrees (e.g., Life Sciences, Healthcare), experience in clinical trial documentationBachelor's degree, certification in clinical research preferred
Work EnvironmentSenior management, overseeing TMF processes across projectsOperational role, supporting trial activities at site or sponsor level
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for document oversightCommonly employed in clinical sites and research organizations

The Director Trial Master File focuses on strategic oversight and management of trial documentation, ensuring compliance and quality. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, including document collection and site coordination. Both roles are essential but differ in scope, responsibilities, and seniority within the clinical research process.

More about Director Trial Master File jobs
What cities are hiring for Director Trial Master File jobs? Cities with the most Director Trial Master File job openings:
What are the most commonly searched types of Trial Master File jobs? The most popular types of Trial Master File jobs are:
What states have the most Director Trial Master File jobs? States with the most job openings for Director Trial Master File jobs include:
What job categories do people searching Director Trial Master File jobs look for? The top searched job categories for Director Trial Master File jobs are:
Director Trial Master File jobs near you
Infographic showing various Director Trial Master File job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 78% In-person, and 22% Remote job distribution, with an average salary of $128,367 per year, or $61.7 per hour.
Senior Clinical Trial Associate

Senior Clinical Trial Associate

Olema Oncology

San Francisco, CA • On-site

$39.50 - $54/hr

Full-time

Posted 5 hours ago

Job description

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond.
You can view our latest corporate deck and other presentations here.
About the Role >>> Senior Clinical Trial Associate
As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines.
This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel.
Your work will primarily encompass:
  • Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct
  • Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors
  • Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
  • Conducts oversight of sample collection, shipment, and analyses
  • Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead
  • Identifies potential risks and proactively resolves issues with CROs
  • Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s)
  • Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information
  • Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents
  • Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms.
  • Coordinates electronic distribution and/or shipment of study-related materials, as appropriate
  • Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed
  • Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)
  • Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations
  • Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes

Ideal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge
  • Bachelor's degree is required
  • Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred
  • Working knowledge of clinical protocols

Experience
  • Minimum of 3 years of related industry experience is required
  • Senior CTA requires 2 years' experience working as a Clinical Trial Associate.
  • Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
  • Experience with leading small group meetings and/or managing vendor relationships

Attributes
  • Highly motivated and enjoys working in a fast-paced, dynamic environment
  • Excellent teamwork and collaboration skills
  • Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
  • Excellent written and verbal communication skills
  • Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed

The base pay range for this position is expected to be $110,000 - $120,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

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