Morrisville, NC · On-site
Negotiates contracts with sites and works with Contracts Manager and Sponsor until resolution of ... Ensure all relevant documents are submitted to the TMF as per requirements. * May be assigned to ...
Morrisville, NC · On-site
Negotiates contracts with sites and works with Contracts Manager and Sponsor until resolution of ... Ensure all relevant documents are submitted to the TMF as per requirements. * May be assigned to ...
Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans ... Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File ...
Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans ... Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File ...
Morrisville, NC · On-site
Performs site qualification, site initiation, interim monitoring, site management activities and ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Morrisville, NC · On-site
Performs site qualification, site initiation, interim monitoring, site management activities and ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Durham, NC · On-site
Supervises site and trial handovers between Site Management Associates Project Coordination Associate * Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares ...
Durham, NC · On-site
Supervises site and trial handovers between Site Management Associates Project Coordination Associate * Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares ...
Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans ... Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File ...
Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans ... Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File ...
Performs site qualification, site initiation, interim monitoring, site management activities and ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Performs site qualification, site initiation, interim monitoring, site management activities and ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Durham, NC · On-site
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
Durham, NC · On-site
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
Durham, NC · On-site
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
Durham, NC · On-site
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$87K - $145K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
Durham, NC · On-site
$87K - $169K/yr
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
Durham, NC · On-site
$87K - $169K/yr
... TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. * Document site management activities, visit outcomes, and follow-up actions through detailed reports and ...
$47K - $169K/yr
Job Overview Perform monitoring and site management work to ensure that sites are conducting the ... File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
$47K - $169K/yr
Job Overview Perform monitoring and site management work to ensure that sites are conducting the ... File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
$87K - $182K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$87K - $182K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$87K - $182K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$87K - $182K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
Durham, NC · On-site
$87K - $169K/yr
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and ... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ...
Durham, NC · On-site
$87K - $169K/yr
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and ... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$71K - $189K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$101K - $169K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$101K - $169K/yr
... TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management ...
$28.04 - $33.99
4% of jobs
$33.99 - $39.93
6% of jobs
$39.93 - $45.88
7% of jobs
$50.34 is the 25th percentile. Wages below this are outliers.
$45.88 - $51.83
9% of jobs
$51.83 - $57.78
15% of jobs
The median wage is $60.40 / hr.
$57.78 - $63.73
18% of jobs
$67.96 is the 75th percentile. Wages above this are outliers.
$63.73 - $69.67
21% of jobs
$69.67 - $75.62
7% of jobs
$75.62 - $81.57
6% of jobs
$81.57 - $87.52
3% of jobs
$87.52 - $93.46
2% of jobs
$28
$60
$93
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.
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.
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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Biotechnology research and development
1,001 - 5,000 Employees
Morrisville, NC, US
2021
