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Tmf Manager Jobs (NOW HIRING)

TMF Group

The commercial focus of the role is to bring in new business for TMF Group's portfolio of services, including HR & Payroll; Global Entity Management; Accounting & Tax; and Trust and Corporate ...

TMF Group

Business Development Director

Miami, FL · On-site +1

The commercial focus of the role is to bring in new business for TMF Group's portfolio of services, including HR & Payroll; Global Entity Management; Accounting & Tax; and Trust and Corporate ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

Ipsen

Clinical Trial Administrator

Cambridge, MA · On-site

Prepare and customize the TMF Management plan, & TMF master index, according to the clinical study specificities, with the CPM and the Document Owners. * Inform the eTMF Support Team of any ...

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How much do tmf manager jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for tmf manager in the United States is $62.52, according to ZipRecruiter salary data. Most workers in this role earn between $50.72 and $70.43 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 in the Tmf Manager position, and why are they important?

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 job?

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 the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $130,034 per year, or $62.5 per hour.
Director, Trial Master File

Director, Trial Master File

Kymera Therapeutics

Watertown, MA • On-site

Full-time

Posted 23 days ago

Job description

Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
  • PIONEER: We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.
  • COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
  • BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you'll make an impact:
  • Lead end-to-end implementation and configuration of the Trial Master File (TMF/eTMF) platform, including system setup, role-based access, workflows, and integration with clinical systems to ensure compliance with regulatory and inspection-readiness standards.
  • Develop, standardize, and implement TMF business processes, SOPs, governance models, and operational workflows across clinical programs, partnering with Clinical Operations, Quality, Regulatory, and IT teams to drive consistent adoption, process efficiency, and scalable execution.
  • Provide strategic and operational leadership for the end-to-end management of the Trial Master File (TMF) across all clinical studies, ensuring inspection readiness throughout the trial lifecycle.
  • Serve as the TMF subject matter expert for the organization, providing guidance to Clinical Operations, Regulatory, Quality, and cross-functional study teams on essential document requirements and best practices.
  • Lead oversight of eTMF systems and service providers, ensuring vendor performance, compliance with contractual obligations, and alignment with sponsor expectations for TMF management.
  • Establish and monitor TMF performance metrics and dashboards (e.g., completeness, timeliness, quality trends), proactively identifying risks and driving corrective actions.
  • Partner closely with Clinical Operations and study teams to ensure TMF activities are integrated into study planning and execution, from study start-up through close-out and inspection readiness.
  • Ensure TMF readiness to support audits, inspections, and regulatory submissions, acting as a central point of contact during TMF-related inspection activities.
  • Lead and execute TMF QC and periodic review activities, including oversight of completeness checks, quality issues, root-cause analysis, and CAPA development.
  • Define and drive TMF training and enablement for internal staff and vendors, ensuring consistent understanding of filing responsibilities and expectations.
  • Maintain alignment between TMF practices and clinical trial oversight, vendor oversight, and protocol deviation management, ensuring documentation supports sponsor oversight obligations.
  • Lead or contribute to continuous improvement initiatives to enhance TMF quality, efficiency, and inspection readiness, including process simplification and system optimization.
  • Ensure timely and compliant TMF close-out, transfer, and archival, including oversight of final reconciliation activities and long-term record retention requirements.

Skills and experience you'll bring:
  • 10+ years of experience in the biotech/pharmaceutical industry with direct experience in TMF management and eTMF system implementation.
  • Proven track record in process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
  • Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
  • Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
  • Proven track record of managing multiple projects and/or programs concurrently
  • Excellent analytical, problem-solving, and organizational skills.
  • Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
  • Demonstrated ability to lead change and foster a culture of continuous improvement.

Equal Employment Opportunity
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
  • Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
  • The anticipated base salary range for this role is $195,000 - $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
  • Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

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