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Tmf Manager Jobs in Washington (NOW HIRING)

MacroGenics, Inc.

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

TMF Delivery and Management * Owns the vendor governance framework, including KPIs, financial oversight and the escalation management for the TMF across all global clinical programs. * Work with the ...

MacroGenics

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

TMF Delivery and Management * Owns the vendor governance framework, including KPIs, financial oversight and the escalation management for the TMF across all global clinical programs. * Work with the ...

New

AST SpaceMobile

OSS Test & Automation Engineer

Lanham, MD · On-site

$46 - $60.50/hr

... management. • Familiarity with telecom OSS concepts like FCAPS, TMF eTOM framework or similar operational support system concepts. • Practical exposure to network operations workflows and/or ...

AST SpaceMobile

OSS Test & Automation Engineer

Lanham, MD · On-site

$46 - $60.75/hr

Strong command of test strategy design, test case development, test automation frameworks, and defect lifecycle management * Familiarity with telecom OSS concepts like FCAPS, TMF eTOM framework or ...

AST SpaceMobile

OSS Test & Automation Engineer

Lanham, MD · On-site

$46 - $60.75/hr

Strong command of test strategy design, test case development, test automation frameworks, and defect lifecycle management * Familiarity with telecom OSS concepts like FCAPS, TMF eTOM framework or ...

AstraZeneca

Regulatory Affairs Manager

Gaithersburg, MD

$109K - $163K/yr

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing ...

AstraZeneca GmbH

Regulatory Affairs Manager

Gaithersburg, MD · On-site

$109.24 - $163.87/hr

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing ...

AstraZeneca

Regulatory Affairs Manager

Gaithersburg, MD · On-site

$109K - $163K/yr

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing ...

Astrazeneca

Regulatory Affairs Manager

Gaithersburg, MD

$109K - $163K/yr

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing ...

AstraZeneca

Regulatory Affairs Manager

Gaithersburg, MD · On-site

$109K - $163K/yr

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing ...

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Tmf Manager information

See Washington salary details

$32

$70

$108

How much do tmf manager jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for tmf manager in Washington is $70.81, according to ZipRecruiter salary data. Most workers in this role earn between $57.45 and $79.76 per hour, depending on experience, location, and employer.

What are some typical challenges a TMF Manager might face in their role?

TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.

What are the key skills and qualifications needed to thrive as a TMF Manager?

To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.

What is a TMF Manager?

A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.

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Tmf Manager jobs near you
Infographic showing various Tmf Manager job openings in Washington as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $147,276 per year, or $70.8 per hour.

Sr. TMF Manager

MacroGenics, Inc.

Rockville, MD • On-site

$34.25 - $46.75/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

Job description

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 150+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities include managing timelines, and deliverables while maintaining quality and regulatory compliance.
Responsibilities and Job Duties:
TMF Planning
  • Partners, collaborates, and develops strong relationships within clinical operations and other functions, to understand the TMF needs to support corporate strategy, corporate objectives, and departmental objectives.
  • Leads enterprise-wide TMF strategy and lifecycle governance across global clinical programs.
  • Monitor technological advances and regulatory evolution and provide an analysis of TMF trends and changes including recommendations to the head of clinical operations for consideration.
  • Leads cross-functional alignment across Clinical Operations, QA, CROs and relevant external partners to drive TMF excellence.
  • Provides input into and/or drives the development of TMF operating procedures, work instructions, training materials, and tools.

TMF Delivery and Management
  • Owns the vendor governance framework, including KPIs, financial oversight and the escalation management for the TMF across all global clinical programs.
  • Work with the head of clinical operations systems to ensure continuing governance with the third-party vendors and that their support is aligned with departmental strategy, goals, and budget.
  • The Senior Manager of TMF Operations is responsible for all aspects of the 3rd party governance with input and oversight from the head of clinical operations systems including determination of key metrics to maintain oversight (% completeness, vendor performance, etc.)
  • Partner with CROs to ensure that system requirements for each trial are set up and delivered per timelines, quality, and budget, and that the end-of-study TMF integration is achieved.
  • Manage and lead TMF-related projects to ensure smooth system delivery and sound project management practices.
  • Maintain effective communication with clinical study teams, CRO staff and TMF vendor personnel throughout study start-up, maintenance and close out.
  • Propose, drive and support process improvement initiatives related to the TMF as required.
  • Lead projects to create, maintain and improve milestones and expected development tracking, timeline reports and dashboards for the TMF.
  • Perform general administrative tasks related to the TMF as required by the clinical study teams, directors, and the head of clinical operations systems.

TMF Inspection Readiness:
  • Work with audit inspection readiness teams, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on study TMF compliance and completeness.
  • Drives inspection readiness strategy, proactively identifying and mitigating TMF risks to ensure successful regulatory inspections.

TMF Subject Matter Expertise
  • Act as the TMF thought leader within MacroGenics, driving innovation through adoption of emerging technologies and industry best practices.
  • Provide principal leadership as the technical consultant for the TMF to ensure that changes and updates are implemented, and the system maintained appropriately.
  • Ensure awareness of trends in the industry in the field of innovation in trial management by scanning external and internal operational trends and evaluating new innovative technologies and practices.
  • Represent TMF technology innovation in trial management and develop a presence in industry-level forums. Act as representative on behalf of the head of clinical operations systems for select meetings and provide updates at operational and staff-wide meetings as required.

Minimum Qualifications
Education and Experience:
  • Bachelor's degree, with preference in physical, life sciences or computer sciences.
  • 7-10 years pharmaceutical industry or CRO experience with at least 4 years in trial management systems, clinical operations, and/or related clinical systems/technology innovation position.
  • Minimum of 4 years of exposure to using TMF on multiple domestic and international trials

Knowledge, Skills, and Abilities:
  • Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) and E6(R3) guidelines
  • Demonstrated knowledge of TMF systems, specifically Veeva TMF.
  • Understanding of the global drug development process, including international standards, health authorities and country/local regulatory requirements.
  • Demonstrated leadership in leading cross-functional teams and high-level project management expertise.
  • Demonstrated qualitative and quantitative skills in redesigning processes, improving productivity, and improving efficiency.
  • Ability to work independently with minimal oversight, however, is aware of when to escalate issues.
  • Excellent strategic thinking skills
  • Demonstrated matrix management skills and ability to influence internally and externally.
  • Excellent communicator and presenter
  • Experience with direct line management of team members or contractors
  • High level of competence and skill with TMF, web-based collaboration tools (MS Teams, SharePoint, etc.)
  • Willingness to travel up to 25%

Supervisory Responsibilities
  • Mentor and develop junior staff
  • May manage staff as required

Additional Information
The annual rate of pay for this position ranges from $144,300-$220,000. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.
The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Statement
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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