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Clinical Tmf Jobs (NOW HIRING)

Systimmune

Associate Director, TMF Operations

Princeton, NJ · On-site

$140K - $180K/yr

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond ... Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs ...

CSL

Senior TMF Lead

King Of Prussia, PA · On-site

Senior TMF Lead (Senior Manager) Work Environment: *** This is a hybrid position based in King of ... Every clinical trial CSL runs depends on a documented, defensible record of how it was conducted ...

CSL

Senior TMF Lead

King Of Prussia, PA · On-site

Senior TMF Lead (Senior Manager) Work Environment: *** This is a hybrid position based in King of ... Every clinical trial CSL runs depends on a documented, defensible record of how it was conducted ...

Fortrea

TMF Lead II - FSP - US

Durham, NC · Remote

$32.25 - $44.25/hr

The TMF Lead II will provide project management principles for all sponsored clinical trials throughout the lifecycle of the trial.TMF Lead II will drive INSPECTION READINESS efforts for the team.

New

CSL

Senior TMF Lead

King Of Prussia, PA · On-site

Senior TMF Lead (Senior Manager) Work Environment: *** This is a hybrid position based in King of ... Every clinical trial CSL runs depends on a documented, defensible record of how it was conducted ...

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How much do clinical tmf jobs pay per hour?

As of Jul 24, 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 (Trial Master File) 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 July 2026, with employment types broken down into 2% As Needed, 73% 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.
Clinical TMF Manager

Clinical TMF Manager

NexInfo Solutions, Inc.

San Francisco, CA • On-site

Other

Posted yesterday

Job description

About Nexinfo
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Our ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Job Title: Clinical TMF Manager, Clinical Operations
Location: San Francisco, CA
Type: Contract to Hire
 
The Opportunity:
This is a unique opportunity for a Clinical Operations Professional. As a Clinical TMF and Systems Manager you will be responsible for acting as a central contact for the Clinical Study Execution Teams (CSETs) for Trial Master File (TMF) management and participating in the development of quality oversight processes for TMF management of clinical trials. Additional responsibilities include the upload, review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). Support Clinical Operations Management in high-level projects, developing processes, strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the TMF Specialist(s) and external vendors, ensuring that study documents are adherent with ICH-Google Cloud Platform guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.
Responsibilities:
  • Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (Google Cloud Platform) and International Conference on Harmonization (ICH) Guidelines
  • Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the clinical trial TMFs and CTMS within timelines and designated program budgets.
  • Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs.
  • Partner with Clinical Study Execution Teams (CSETs), CROs/vendors and cross-functional team members to align TMF activities, as needed.
  • Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic).
  • Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed.
  • Provides TMF SME audits and inspections support.
  • Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations.
  • Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.
  • May be responsible for direct TMF management activities, e.g., for assigned study TMF(s)
  • Responsible for contributing to risk management, contingency and scenario planning.
  • Analyze and report TMF health metrics by study to be shared with stakeholders.
  • Supervise, communicate system status, issues and problem solves to ensure project team goals are met.
  • Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs)
  • Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals.
  • Participate in and/or co-lead departmental or interdepartmental strategic business initiatives, as well as contribute to SOP development, implementation, and training.
  • Manage staff through mentorship and may supervise TMF specialist(s) or similar as direct reports.
  • Assists in the hiring, development, and retention of top talent within the team. Coaches direct report(s) on their performance, development, and career interests.
  • Participate in other Clinical Operations activities as appropriate.
Required Skills, Experience and Education:
  • RN or bachelor s or master s degree desired.
  • Minimum of 8+ years working in a pharmaceutical or other highly regulated corporate environment.
  • Minimum of 6 years experience working in the Records Management field, including 4+ years experience using electronic records management systems. Relevant indirect experience may also meet this requirement.
  • Strong experience collaborating with the DIA (CDISC) TMF Reference Model.
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and Google Cloud Platform.
  • Strong experience in Trial Master File requirements and set up.
  • Strong knowledge of electronic document management systems, document archival systems: (eTMF) and CTMS systems.
  • A clear understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites.
  • Ability to successfully oversee study TMFs including development of relevant processes and policies.
  • Experience in selection of CROs/vendors and management of external resources.
  • Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Excellent written/verbal communication and people skills.
  • Strong decision-making skills.
  • High sense of priority and commitment to excellence in the successful execution of deliverables.
  • Ability to analyze operational data, contribute with a mindset focused on quality, timeliness and fiscal responsibility, drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Process and Systems team.
  • Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
Preferred Skills:
  • Has direct experience working with eTMF systems.
  • Has familiarity collaborating with vendor systems/portals (e.g., CTMS).
  • Oncology experience, early and/or late stage, preferred.
  • Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
  • Experience managing direct reports(s).

Thanks and Regards,

Joseph

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