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Director Trial Master File Jobs (NOW HIRING)

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 ...

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 ...

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 ...

Specialist Study Management

Wilmington, DE · On-site

$33.75 - $45.25/hr

Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form ...

... activation, and Trial Master File inspection readiness. * Ensure studies are conducted in ... direct-to-participant research, or hybrid study models. * Deep expertise in clinical trial ...

... activation, and Trial Master File inspection readiness. * Ensure studies are conducted in ... direct-to-participant research, or hybrid study models. * Deep expertise in clinical trial ...

... activation, and Trial Master File inspection readiness. * Ensure studies are conducted in ... direct-to-participant research, or hybrid study models. * Deep expertise in clinical trial ...

... activation, and Trial Master File inspection readiness. * Ensure studies are conducted in ... direct-to-participant research, or hybrid study models. * Deep expertise in clinical trial ...

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Clinical Study Manager

Durham, NC · On-site

$57 - $71/hr

Maintain Trial Master File (TMF) quality, reconciliation, and inspection readiness. * Review and approve study documentation, including informed consent forms, monitoring plans, laboratory manuals ...

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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 Jul 15, 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 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.

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.
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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:
Infographic showing various Director Trial Master File job openings in the United States as of July 2026, with employment types broken down into 50% Full Time, and 50% Part Time. Highlights an 75% In-person, and 25% Hybrid job distribution, with an average salary of $128,367 per year, or $61.7 per hour.
CTA Clinical Trial Assistant (support role) - hybrid in Minneapolis

CTA Clinical Trial Assistant (support role) - hybrid in Minneapolis

CVRx, Inc.

Brooklyn Park, MN • Hybrid

Full-time

Medical, Dental, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Job description

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

This position is hybrid onsite at our Brooklyn Park, MN headquarters and our ideal candidate will reside locally.  

The Role
At CVRx, the Clinical Trial Assistant is a administrative support professional who will collaborate with cross-functional teams within the Clinical Research Department to assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES
  • Maintain and organize clinical trial documentation, including study files, essential documents, and correspondence.
  • Assist in the collection and tracking of study documents.
  • Maintains the Trial Master File (TMF) to ensure inspection-readiness at all times, including quality control review of documents to ensure compliance with GCP.
  • Track and follow-up on outstanding site documentation and administrative requirements.
  • Assist with data reconciliation, and maintenance of administrative and operational data within clinical trial systems
  • Prepare and distribute meeting agenda's, meeting minutes, and action items to Clinical team.
  • Update TMF, CTMS, EDC management systems, when needed.
  • Assists in trial activities such as processing payments, running reports, tracking study deliverables as needed.
  • Maintains trial related trackers, logs and internal dashboards,
  • Support study start-up activities, including review and maintenance of regulatory document and site initiation materials.
  • Perform ad-hoc and cross-functional duties and/or projects, as assigned by manager or supervisor
REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
  • Bachelor's Degree (health or life sciences preferred) or a combination of education and experience will be considered

  • 1-2 years experience in a clinical research operations support role

  • Knowledgeable in FDA regulations for medical device research, ISO 14155 for GCP (Good Clinical Practices)

  • Experience working in Electronic Trial Master File (eTMF) Systems (e.g. Florence).

  • Experience working in Electronic Data Capture (EDC) Systems (e.g. iMednet).

  • Excellent interpersonal, verbal, and written communication skills; able to effectively work across departments with diverse sets of needs

  • Excellent organizational and time management skills

  • High work standards and ethics and a passion for success

  • Outstanding attention to detail and emphasis on accuracy

  • Able to maintain confidentiality when required and operate in a highly regulatory environment

  • Proficient in Microsoft Office Suite (Office 365)

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
  • Prior experience with cardiovascular medical device research studies

  • Prior experience working with disruptive medical devices

  • Prior experience in a growth or start-up stage company

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT
  • Normal office conditions

  • Must be able to sit/stand/walk 8 hours per day.

  • Ability to travel for business as required up to 10% by car and/or air could be required

CVRx is unable to provide employment visa sponsorship for this position. Candidates must be legally authorized to work in the United States without current or future sponsorship
 
 
What we offer:
CVRx is proud to offer competitive salaries and benefits plans.
 
We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.
 
The hourly pay rate for this position in Minnesota (required) is 24.00 - 29.00 per hour USD
 
The pay range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location. 
 
We also offer a competitive and rewarding benefits package, details listed below:
* Competitive Health & Dental Insurance options with generous Company contributions
* Company contributions to an HSA with a high deductible insurance plan selection
* 401(k) with a company match
* Employee stock purchase plan (ESPP) & stock option and restricted stock unit grants
* 12 company-paid holidays per year in addition to a generous Flex PTO plan
* Generous paid time off for new parents
* Company-paid life insurance & disability options
* Unlimited growth opportunities in a growing company
* Endless training & learning opportunities
* Flexible Schedule
 
EEO STATEMENT
CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 
 
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.  
 
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!   
 
If you need assistance or an accommodation due to a disability, you may contact us at [email protected] 
CVRx Privacy Policy 
CVRx SMS Terms of Service 
 
This requisition will be open until filled.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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