Senior TMF Lead
King Of Prussia, PA · Hybrid
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · Hybrid
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · Hybrid
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
Naples, FL · On-site
Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality ...
Naples, FL · On-site
Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Princeton, NJ · On-site
$109K - $149K/yr
Accountable for Clinical Data Management system validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness. REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Bachelor ...
Princeton, NJ · On-site
$109K - $149K/yr
Accountable for Clinical Data Management system validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness. REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Bachelor ...
Whippany, NJ · On-site
$65 - $70/hr
Life Sciences R&D GxP experienced Global Program Manager (for client's program scope) with experience in successfully program managing a Veeva Vault Clinical (CTMS, Site Connect preferred else eTMF ...
Quick apply
Whippany, NJ · On-site
$65 - $70/hr
Life Sciences R&D GxP experienced Global Program Manager (for client's program scope) with experience in successfully program managing a Veeva Vault Clinical (CTMS, Site Connect preferred else eTMF ...
Boston, MA · On-site
This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of ...
Quick apply
Boston, MA · On-site
This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Quick apply
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Malvern, PA · On-site
$32.75 - $45/hr
Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system ...
Malvern, PA · On-site
$32.75 - $45/hr
Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system ...
Chesapeake, VA · On-site
$110 - $170/hr
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready". * Ensures that all study documents are ready for final ...
Chesapeake, VA · On-site
$110 - $170/hr
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready". * Ensures that all study documents are ready for final ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
King Of Prussia, PA · On-site
TMF Systems & Innovation - Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best ...
Princeton, NJ · On-site +1
$109K - $149K/yr
Accountable for Clinical Data Management system validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness. REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Bachelor ...
Princeton, NJ · On-site +1
$109K - $149K/yr
Accountable for Clinical Data Management system validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness. REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Bachelor ...
Supervises the study TMF set-up in the eTMF/EDMS system and develops any trial-specific instructions/documentation for the Clinical Documentation Team. Provides support and direction to the Clinical ...
Supervises the study TMF set-up in the eTMF/EDMS system and develops any trial-specific instructions/documentation for the Clinical Documentation Team. Provides support and direction to the Clinical ...
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Quick apply
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Peru, IL · On-site
$90 - $120/hr
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready". * Ensures that all study documents are ready for final ...
Peru, IL · On-site
$90 - $120/hr
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready". * Ensures that all study documents are ready for final ...
New York, NY · On-site
$135K - $160K/yr
We are looking for a commercial SME with deep domain expertise and a track record selling Clinical Operations cloud platforms - CTMS, eTMF, and Site Payments - to MedTech companies. You will be the ...
New York, NY · On-site
$135K - $160K/yr
We are looking for a commercial SME with deep domain expertise and a track record selling Clinical Operations cloud platforms - CTMS, eTMF, and Site Payments - to MedTech companies. You will be the ...
New York, NY · On-site
$135K - $160K/yr
We are looking for a commercial SME with deep domain expertise and a track record selling Clinical Operations cloud platforms - CTMS, eTMF, and Site Payments - to MedTech companies. You will be the ...
New York, NY · On-site
$135K - $160K/yr
We are looking for a commercial SME with deep domain expertise and a track record selling Clinical Operations cloud platforms - CTMS, eTMF, and Site Payments - to MedTech companies. You will be the ...
$110K - $138K/yr
Maintain up-to-date documentation in CTMS and eTMF systems * Support and track site staff training and maintain compliance records * Monitor patient safety, ensuring timely and accurate AE/SAE/PQC ...
$110K - $138K/yr
Maintain up-to-date documentation in CTMS and eTMF systems * Support and track site staff training and maintain compliance records * Monitor patient safety, ensuring timely and accurate AE/SAE/PQC ...
$34.5K - $43.2K
2% of jobs
$43.2K - $52K
0% of jobs
$52K - $60.7K
0% of jobs
$60.7K - $69.4K
4% of jobs
$69.4K - $78.1K
11% of jobs
$85.7K is the 25th percentile. Wages below this are outliers.
$78.1K - $86.9K
9% of jobs
The median wage is $94.1K / yr.
$86.9K - $95.6K
28% of jobs
$95.6K - $104.3K
20% of jobs
$104.6K is the 75th percentile. Wages above this are outliers.
$104.3K - $113K
8% of jobs
$113K - $121.8K
7% of jobs
$121.8K - $130.5K
9% of jobs
$34.5K
$96.2K
$130.5K
As an eTMF Specialist, your daily responsibilities include managing, organizing, and maintaining essential clinical trial documents within the electronic Trial Master File system. You will monitor document completeness, track filing timelines, and ensure regulatory compliance, often collaborating with clinical, regulatory, and quality assurance teams. Regular audits, resolving document discrepancies, and training other team members on eTMF processes are also common tasks. The role requires staying up to date with changing regulatory requirements and maintaining clear communication with multiple stakeholders to support successful clinical trial operations.
An eTMF (electronic Trial Master File) job involves managing and maintaining digital documentation related to clinical trials. Professionals in this role ensure regulatory compliance, organize essential trial documents, and support inspection readiness. They may use eTMF systems to track, classify, and archive trial-related files. Strong attention to detail and knowledge of clinical research regulations are essential.
To thrive as an eTMF (electronic Trial Master File) Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements, and document management best practices, often supported by a degree in life sciences or a related field. Familiarity with eTMF systems such as Veeva Vault or Medidata, as well as relevant certifications like the DIA TMF Certificate, is highly beneficial. Attention to detail, excellent organizational skills, and effective cross-functional communication make candidates stand out in this role. These competencies are crucial for ensuring that clinical trial documentation is complete, inspection-ready, and compliant with industry regulations.
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Senior TMF Lead (Senior Manager)
Work Environment:
*** This is a hybrid position based in King of Prussia, PA or Maidenhead, UK with a minimum of 3 days onsite in the designated work location weekly. Relocation and mobility assistance are not provided.
Position Overview:
Every clinical trial CSL runs depends on a documented, defensible record of how it was conducted — the Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they need to know that a study was run to standard, from first patient in to final archive. Get the TMF right, and inspections go smoothly, submissions move forward, and study teams can focus on the science instead of scrambling for documentation. Get it wrong, and everything downstream slows down.
We're looking for a Senior TMF Lead to take day-to-day ownership of that record across our full therapeutic portfolio — not as an administrative function, but as a genuine operational discipline with its own standards, technology, and continuous improvement agenda.
You'll work closely alongside the Associate Director as a trusted partner on project management and TMF Operations standards, including people management, processes, and systems.
Key Responsibilities:
You'll provide oversight and hands-on management for a team supporting TMF operations across all of CSL's therapeutic areas, reporting to the Associate Director, TMF Operations — Portfolio Development Excellence, Process and Compliance. In practice, that means:
Who you'll work with:
You'll sit as a key stakeholder in the TMF Operations management team, working very closely with the Associate Director and Managers. In parallel, you'll work regularly with the Study File Specialists working across studies. Cross-functionally, TMF reaches all functions, and you'll build close relationships with Clinical Compliance, Study Management, and leaders across the organization. In addition, you'll collaborate with counterparts at various vendors and External Service Providers. It's a role built on relationships as much as process, and one where the quality of your judgment shows up in how ready CSL is, at any given moment, to open its files to an inspector and stand behind what's inside.
Minimum Qualifications:
Preferred Qualifications:
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Commonwealth Serum Laboratories (CSL) is a global leader in biotechnology, based in King of Prussia, Pennsylvania. The company originates from Australia, founded in 1916 by the Australian government to service the country’s health needs. Since then, CSL has expanded operations to become a multinational specialty biotechnology company that researches, develops, and manufactures vaccines and plasma protein biotherapies. Their mission is underpinned by focused, patient-driven values. Our commitment to saving lives and protecting people's health by providing safe and effective products is a testament to the difference we are making. One of their considerate achievements includes establishing one of the largest influenza vaccine providers in the world through their brand Seqirus.
Scientific research and development services
10,000+ Employees
King of Prussia, PA, US