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Director Trial Master File Jobs in Tennessee (NOW HIRING)

IQVIA

CRA 1, IQVIA Biotech

Franklin, TN · On-site

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

IQVIA

CRA 1, IQVIA Biotech

Elizabethton, TN · On-site

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

IQVIA

CRA 1, IQVIA Biotech

Elizabethton, TN · On-site

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

IQVIA

CRA 1, IQVIA Biotech

Franklin, TN · On-site

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

Epitec

Sr Trial Attorney.

Nashville, TN · On-site

$100K/yr

Type: Direct Hire * Job #106160 * Salary: $100,000 In this role, you will independently manage a ... Advises claim professionals on the evaluations of legal files * Provides legal advice to clients ...

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Director Trial Master File information

What are the roles and responsibilities of a director trial master file?

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 are the key skills and qualifications needed to thrive as a director trial master file?

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 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 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 most commonly searched types of Trial Master File jobs in Tennessee?

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

What are popular job titles related to Director Trial Master File jobs in Tennessee?

For Director Trial Master File jobs in Tennessee, the most frequently searched job titles are:

What job categories do people searching Director Trial Master File jobs in Tennessee look for?

The top searched job categories for Director Trial Master File jobs in Tennessee are:

What cities in Tennessee are hiring for Director Trial Master File jobs?

Cities in Tennessee with the most Director Trial Master File job openings:

Director Trial Master File jobs near you
Infographic showing various Director Trial Master File job openings in Tennessee as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution.

Clinical Study Manager

Medacta USA, Inc.

Franklin, TN • On-site

Full-time

Posted 11 days ago

Job description

MEDACTA INTRODUCTION
Medacta® is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements, leading to minimally invasive approaches. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.
POSITION SUMMARY
Under the direction of the Director of Clinical Research, the Clinical Study Manager is responsible for managing and monitoring of the Medacta USA (MUSA) routine clinical trial activities. The role is responsible for ensuring that MUSA's clinical research activities are performed to the highest quality and ethical standards. The position will require flexibility and the ability to work both independently and in a small team environment.
QUALIFICATIONS
Educational Requirements:
Bachelor's Degree in a related healthcare discipline. Clinical research experience in lieu of a degree shall be considered. Certified clinical research professional preferred. Knowledge of IRB policies, ICH GCP guidelines, FDA regulations.
Experience Requirements
5+ years of clinical research experience, clinical monitoring and study experience preferred.
Required Skills and Abilities:
  • Experience with study and site level management of clinical trials, including but not limited monitoring clinical trials.
  • Ability to work independently, including off-site travel.
  • Strong computer skills, including prior experience with clinical research data systems.
  • Ability to maintain tact, poise, and discretion in handling confidential matters.
  • Highly organized and detail oriented. Ability to analyze and solve problems.
  • Ability to handle multiple tasks concurrently. Excellent time management skills.
  • Physical Requirements
    • Sitting: Extended periods at a desk or workstation.
    • Standing and Walking: Frequent movement within the office.
    • Lifting and Carrying: Light to moderate lifting of office materials, supplies, etc.

Additional tasks may require reaching, manual dexterity, and visual acuity.
INTERPERSONAL CONTACTS
External: Medical professionals, surgeons, nurses, clinical study professionals, clinical research related vendors
Internal: Marketing, Research and development, Clinical Research
Travel requirements: 50-70%
Extent of Confidential Information: This position occasionally will encounter confidential information which will be treated according to the company policy to ensure all information is protected.
Reporting: Clinical updates to internal colleagues
PRINCIPAL DUTIES
  • Oversee and/or contributes to the preparation of clinical documents, e.g., protocols, investigator brochure, annual report updates, case report forms and clinical study reports, monitoring plans, and budgets.
  • Maintains and manages all aspects of studies including protocol, CRF and database development, site recruitment, budget and agreement negotiation, study initiation, trial maintenance, data monitoring, data reporting, trial master file maintenance, and product and payment tracking.
  • Utilizes communications, reports, EDC systems to proactively identify potential barriers to project completion and data integrity and proactively implements effective strategies to correct/avoid such barriers.
  • Demonstrates problem-solving strategies and develops alternative solutions and contingencies to address issues as they occur; instills a practice of continuous improvement with team.
  • Drafts/updates, reviews standard operating procedures, work instructions, and controlled forms
  • Develops and implements training plans for sites, ensuring skills and certifications are timely relative to assigned projects.
  • Perform monitoring and/or auditing of investigative sites, CROs, and MUSA study files.
  • Ensure site compliance while conducting qualifications, study initiation, routine monitoring, and study site close-out visits for research sites according to Medacta's Standard Operating Procedures (SOPs);
  • Provide training and guidance to Principal Investigator and site staff regarding compliance with research regulations and guidelines, the clinical protocol, and data collection requirements.
  • Assist in reporting and follow-up of clinical unexpected and Serious Adverse Event (SAE) reporting.
  • Ensure all critical documents related to clinical trials are organized and maintained in audit-ready condition.
  • Monitor (as needed) study investigational product, supply inventory, and destruction according to SOPs and regulations.
  • Conduct travel according to company policy, which is expected to be between 30-50% (or may be less due to virtual site monitoring) yet may fluctuate depending on project needs.

OCCASIONAL DUTIES
Other duties may be assigned at Medacta USA's discretion.

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