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Associate Director Tmf Jobs (NOW HIRING)

Associate Director, Clinical Research 3 days ago Requisition ID: 1100 Salary Range: $190,000.00 To ... Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes. * Perform tasks ...

## Associate Director, Clinical Site Management and Monitoring OversightApplylocations: TN - Tennessee ... Recent experience with Veeva Vault systems (TMF, CTMS)* **Critical Competencies for Success ...

Global Study Associate Director Location: Durham, NC Introduction to role: Are you ready to lead ... Oversee TMF strategy, plan, and Expected Document List; ensure ongoing QC and continuous inspection ...

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Associate Director Tmf information

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How much do associate director tmf jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for associate director tmf in the United States is $39.99, according to ZipRecruiter salary data. Most workers in this role earn between $32.21 and $43.99 per hour, depending on experience, location, and employer.

What are the roles and responsibilities of an Associate Director TMF?

An Associate Director TMF (Trial Master File) is responsible for overseeing the management, quality, and compliance of TMF documentation in clinical trials. They ensure that all essential documents are collected, maintained, and archived according to regulatory requirements and company policies. The role often includes leading TMF teams, developing SOPs, training staff, and collaborating with cross-functional teams to support inspection readiness. Associate Directors also monitor TMF metrics, conduct audits, and implement process improvements to ensure efficient and compliant TMF operations.

What skills and qualifications are needed to thrive as an Associate Director TMF?

To excel as an Associate Director TMF (Trial Master File), you need in-depth knowledge of clinical trial documentation, regulatory requirements, and quality management principles, typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF systems (eTMF), GCP guidelines, and industry-standard document management software is crucial. Exceptional organizational skills, attention to detail, and effective leadership and communication abilities set top performers apart. These skills ensure the integrity, compliance, and efficiency of clinical trial documentation, which is vital for successful regulatory submissions and trial outcomes.

What are the typical responsibilities and team interactions for an Associate Director TMF within a clinical research organization?

As an Associate Director TMF (Trial Master File), you will oversee the management and quality of TMF documentation to ensure compliance with regulatory standards. Your daily responsibilities often include leading TMF strategy, supervising document management teams, coordinating with clinical project managers, and supporting audits or inspections. Collaboration is key in this role, as you work closely with cross-functional teams such as clinical operations, quality assurance, and regulatory affairs to ensure seamless documentation processes. This position also offers opportunities to mentor team members and drive process improvements, contributing to both personal and organizational growth.

What is the difference between Associate Director Tmf vs Clinical Trial Manager?

AspectAssociate Director TmfClinical Trial Manager
Required CredentialsBachelor's or higher in life sciences, often with experience in TMF managementBachelor's or higher in life sciences, with clinical trial management experience
Work EnvironmentPharmaceutical or biotech companies, overseeing TMF processesClinical research sites or sponsors managing trial operations
Employer & Industry UsageUsed in pharmaceutical and biotech industries for TMF oversightCommon in clinical research organizations and sponsors for trial execution

The Associate Director Tmf primarily focuses on overseeing Trial Master File processes and compliance, often in a strategic capacity, while the Clinical Trial Manager handles the day-to-day management of clinical trials. Both roles require strong knowledge of clinical trial operations, but the Associate Director Tmf emphasizes document oversight and regulatory adherence, whereas the Clinical Trial Manager concentrates on trial execution and site management.

What are popular job titles related to Associate Director Tmf jobs?

For Associate Director Tmf jobs, the most frequently searched job titles are:

Infographic showing various Associate Director Tmf job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 68% Full Time, 28% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $83,169 per year, or $40 per hour.

Associate Director, Clinical Operations

North Bethesda, MD • On-site

Technical Resources International, Inc.
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees

$130K - $175K/yr

Other

Re-posted 14 hours ago


Key responsibilities

  • Oversee clinical operations activities such as project management, site management, and systems management.

  • Manage project deliverables within budget and timelines across multiple functional areas and programs.

  • Collaborate with cross-functional teams to develop and implement clinical operations strategies and ensure documentation and process compliance.


Job description

Associate Director, Clinical Operations - (ADCO_COMPANY_1.5)

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Job Title

Associate Director, Clinical Operations

Location

Bethesda, MD 20817 US (Primary)

Category

Clinical Operations

Job Type

Full-Time

Salary Range

$130,000-175,000/YEAR

Education

Bachelor's Degree

Travel

None

Job Description
  • Oversight of clinical operations activities, including one or more of the following: clinical project management, clinical site management (essential regulatory documents, study start up, site monitoring), and/or clinical systems management (CTMS, TMF documentation review/ collection) with an understanding and working knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and scientific/ technical writing processes and requirements.
  • Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse.
  • Responsible for project management oversight for multiple functional areas within one or more complex drug development programs while managing deliverables within budget and to well-defined timelines.
  • Effectively communicates in a matrix management organization with the ability to represent the clinical team during cross-functional collaboration.
  • Provides operational expertise to support program/project level functional areas.
  • Collaborates with Director and other departments and leads on clinical operations strategy and vision to support clinical trial activities.
  • Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation
  • Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
  • Support and comply with the company’s Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client.
  • Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development
  • Includes line management responsibility and staff hiring activities. Responsible for resource management, tracking, and level of effort projections for one or more groups in the clinical operations department and/or project functional areas.
  • Participate in proposal writing for government and commercial clients, budget development, and bid defense meetings, as needed.
  • Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up.
Job Requirements
  • Broad multidisciplinary understanding of the pharmaceutical clinical research and development processes with hands on regulatory, clinical operations, or clinical trial monitoring/management experience, e.g., clinical study design, conduct, management, reporting, and/or product development life cycle.
  • Able to mentor staff and achieve high quality performance through risk management/ mitigation and implementation of corrective/ preventive actions, as needed.
  • Strong facilitation, presentation, and problem-solving, and conflict resolution skills; including ability to keep up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools.
  • Strong leadership skills including change management, people development, strategic thinking, and influencing.
  • Advanced ability to manage team resources to ensure attainment of department objectives.
  • Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project.
  • Proposal writing and bid defense skills a plus.
  • Background in Infectious Disease/HIV clinical trials and/or Oncology; or experience in the conduct of Phase 1 protocols or prior work on a government contract, is a plus.
  • 10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other clinical trials or research environment, e.g., hands on regulatory, clinical operations (in-house CRA or study coordinator), site monitoring, or TMF experience, including at least 6 years of project management (PM) or equivalent clinical trials and operations management experience.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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