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Clinical Tmf Jobs (NOW HIRING)

Integrated Resources INC

... clinical trial documentation and preclinical study records ... Participate in continued security and maintenance of the Trial Master File (TMF) Room.

Doist

Director, Clinical Development Systems

Bothell, WA · On-site

$229 - $256/hr

Lead cross-functional planning and delivery of TMF and CTMS implementation and modernization, including business process design, configuration, data migration, integration validation, training ...

New

Laborie

Clinical Project Manager

Minnetonka, MN

$130K - $135K/yr

Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing ...

Verastem

Clinical Trial Associate

Boston, MA · On-site

$86K - $100K/yr

Uploads and reviews TMF documents for completeness, accuracy and compliance with protocol and ... Coordinates cross function project team meetings with Clinical Project Manager and assists in ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site +1

$32.25 - $44/hr

The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution ...

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Clinical Tmf information

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How much do clinical tmf jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for clinical 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 is a clinical TMF?

A Clinical TMF, or Trial Master File, is a collection of essential documents that are used in clinical trials to demonstrate compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. It includes all documents related to the planning, conduct, and management of a clinical study. Maintaining an accurate and complete TMF is crucial for ensuring the integrity of the trial and for audits by regulatory authorities. The TMF can be maintained in paper, electronic, or hybrid formats, and is typically managed by Clinical TMF Specialists or teams within pharmaceutical or clinical research organizations.

What is the difference between Clinical Tmf vs Clinical Data Manager?

AspectClinical TmfClinical Data Manager
CredentialsTypically requires life sciences degree, TMF-specific trainingRequires degree in life sciences, biostatistics, or related field, often with data management certifications
Work EnvironmentWorks closely with clinical trial documentation, regulatory teamsFocuses on data collection, validation, and database management
Industry UsageUsed in clinical trial documentation and regulatory complianceUsed in data collection, cleaning, and analysis in clinical research

While both roles are essential in clinical research, Clinical Tmf specialists focus on managing trial documentation and regulatory files, whereas Clinical Data Managers handle data collection and analysis. Understanding these differences helps in choosing the right career path or job search focus.

What are the key skills and qualifications needed to thrive as a clinical TMF specialist, and why are they important?

To thrive as a Clinical TMF Specialist, you need strong organizational skills, attention to detail, and a solid understanding of clinical trial documentation and regulatory requirements, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management software, and Good Clinical Practice (GCP) guidelines is typically required. Excellent communication, problem-solving abilities, and the capacity to work independently make candidates stand out in this role. These skills ensure accurate documentation, compliance with regulatory standards, and smooth clinical trial operations.

What are some common challenges faced by clinical TMF professionals, and how can they be managed?

Clinical TMF (Trial Master File) professionals often encounter challenges related to maintaining TMF completeness, ensuring document accuracy, and meeting strict regulatory timelines. Coordinating with multiple stakeholders—such as clinical operations, quality assurance, and external vendors—requires strong organizational and communication skills. Proactively implementing robust tracking systems, conducting regular quality control checks, and fostering a culture of continuous training can help manage these challenges effectively and ensure compliance with industry standards.
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What job categories do people searching Clinical Tmf jobs look for?

The top searched job categories for Clinical Tmf jobs are:

Infographic showing various Clinical Tmf job openings in the United States as of August 2026, with employment types broken down into 3% As Needed, 72% Full Time, 17% Part Time, and 8% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $83,169 per year, or $40 per hour.

Associate Director, Clinical Compliance & Records

Amylyx Pharmaceuticals

Cambridge, MA • On-site

Full-time

Re-posted 12 days ago

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Associate Director, Clinical Compliance & Records will work closely and collaboratively with Clinical Operations leadership and Study Management Teams (SMTs) to ensure that Amylyx clinical studies are conducted in compliance with Standard Operating Procedures (SOPs), ICH/GCP, and other applicable regulations. Reporting to the Director, Clinical Compliance & Records, this role will participate in SMTs, providing leadership for TMF strategy and process, and partnering with internal and external stakeholders on inspection readiness initiatives, supporting management of overall compliance and identifying and implementing process improvement strategies.
Responsibilities: Clinical Compliance
  • Provide Study Management Teams (SMTs) with guidance on the application of ICH-GCP standards, FDA guidelines, and other applicable regulatory requirements throughout the clinical trial lifecycle.
  • Apply clinical compliance knowledge to identify, assess, trend, and manage study-related risks and issues. Lead or support investigations, CAPA activities, and continuous process improvement initiatives. Escalate significant quality and compliance risks to departmental leadership.
  • Partner with Clinical Operations and cross-functional SMT members to support Quality Event (QE) management, including maintaining Oversight Registers, facilitating risk and impact assessments, updating Risk Assessment Categorization Tools (RACTs), and ensuring the development and maintenance of sponsor oversight documentation, such as storyboards and supporting evidence packages.
  • Partner with SMTs and other members of the Clinical Compliance and Records team to create and maintain study-specific training matrices. Ensure SMT members are trained on appropriate study documents per study-specific training matrices.
  • Collaborate with Quality Assurance and Clinical Operations to ensure that Clinical Operations written standard operating procedures, forms, and templates meet the changing needs of the organization.
  • Create and manage a periodic review schedule, to ensure that Clinical Operations written SOPs, forms, and templates are assessed in a timely fashion and in conjunction with defined procedures.
  • Create and manage periodic review schedules for study plans and evaluations of adherence to defined processes.
  • Facilitate and support inspection readiness activities by collaborating with Clinical Operations, SMTs, and Clinical Quality to ensure appropriate preparation for, participation in, and follow-up from Regulatory inspections and internal audits. This may include tracking of follow up actions resulting from inspections and audits.
  • Serve as support for and back-up to Director, Clinical Compliance and Records, providing guidance and leadership for the Clinical Compliance team and operations, ensuring alignment with departmental goals and organizational priorities.

Responsibilities: Clinical Records
  • Provide leadership for Clinical Records strategy, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans and associated indexes, TMF migrations, change controls, deviations and CAPAs.
  • Establish, follow, and oversee processes for TMF set up, maintenance, and archival across Amylyx clinical studies.
  • Oversee and facilitate the eTMF access process. Ensure appropriate internal and external user permissions by monitoring, granting, modifying, and revoking access as needed.
  • Serve as TMF Subject Matter Expert, supporting cross-functional departments to ensure high quality documentation and appropriate TMF structure. Collaborate with internal and external stakeholders to resolve TMF quality issues.
  • Monitor TMF health and provide study-specific metrics according to the TMF Plan.
  • Participate in the development and delivery of Veeva Clinical (eTMF) training for internal and external users.
  • Support audit and inspection readiness activities, including TMF preparation.
  • Identify and implement process improvements in collaboration with key stakeholders to aid with the improvement of TMF efficiency, usability, and compliance.
  • Lead migrations of TMF content to Veeva Clinical (eTMF), if needed, working with Director, Clinical Compliance and Records to define resourcing and efforts required to complete TMF migrations.
  • Ensure TMF content and metadata meet departmental standards, good documentation practices, and Good Clinical Practice (GCP) requirements.
  • Serve as support for and back-up to the Director of Clinical Compliance and Records, providing guidance and leadership for the TMF operations team and/or other clinical roles involved in TMF activities, ensuring alignment with departmental goals and organizational priorities.

Required Qualifications
  • Bachelor's Degree in a health related or scientific discipline with 8+ years of pharmaceutical or biotechnology industry experience, working in Clinical Compliance and/or TMF focused roles.
  • Experience with the interpretation and application of ICH/GCP standards and FDA guidelines to varying phases of clinical studies.
  • High level of competency with TMF Standard (i.e., TMF Reference Model), and working knowledge of Veeva Clinical and Veeva Quality workflows preferred.
  • Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
  • Excellent interpersonal and professional skills and ability to work collaboratively across functional teams.
  • Strong organizational and time management skills.
  • Excellent communication skills, both oral and written.
  • Must have the enthusiasm to work at a small company and work in a fast-paced environment and be ready to dive right in once hired.
  • Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.

Preferred Requirements
  • Prior experience supporting and/or participating in US FDA, EMA, MHRA or other health authority inspections
  • Prior experience as a Business Administrator over electronic Trial Master File systems.

Work Location and Condition
  • At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
    • You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
    • You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.
Estimated Pay Range
$171,000-$192,000 USD
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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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