... Trial Master File (TMF), and clinical trial registry submissions. * Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and ...
Quick apply
... Trial Master File (TMF), and clinical trial registry submissions. * Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and ...
Quick apply
... Trial Master File (TMF), and clinical trial registry submissions. * Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and ...
... Trial Master File (TMF), and clinical trial registry submissions. * Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and ...
... Trial Master File (TMF), and clinical trial registry submissions. * Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and ...
Experience with electronic data capture (EDC), clinical trial management systems (CTMS), interactive voice response systems (IVRS), and electronic trial master file (eTMF). * Knowledge of applicable ...
Experience with electronic data capture (EDC), clinical trial management systems (CTMS), interactive voice response systems (IVRS), and electronic trial master file (eTMF). * Knowledge of applicable ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $145K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Morrisville, NC · On-site
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Morrisville, NC · On-site
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Morrisville, NC · On-site
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Morrisville, NC · On-site
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Durham, NC · On-site
$105K/yr
Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality. * Manage project specific eTraining and oversee compliance. * Coordinate and support onboarding of ...
Durham, NC · On-site
$105K/yr
Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality. * Manage project specific eTraining and oversee compliance. * Coordinate and support onboarding of ...
Durham, NC · On-site
$112K/yr
Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality. Manage project specific eTraining and oversee compliance. Coordinate and support onboarding of new ...
Durham, NC · On-site
$112K/yr
Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality. Manage project specific eTraining and oversee compliance. Coordinate and support onboarding of new ...
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up deliverables. * Coordinate with Feasibility and Clinical Operations to support site identification ...
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up deliverables. * Coordinate with Feasibility and Clinical Operations to support site identification ...
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up deliverables. * Coordinate with Feasibility and Clinical Operations to support site identification ...
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up deliverables. * Coordinate with Feasibility and Clinical Operations to support site identification ...
Durham, NC · On-site
$87K - $169K/yr
May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is ...
Durham, NC · On-site
$87K - $169K/yr
May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is ...
Durham, NC · On-site
$87K - $182K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $182K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$49K - $175K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH ...
Durham, NC · On-site
$49K - $175K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH ...
Durham, NC · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $182K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Durham, NC · On-site
$87K - $182K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
$11.15 - $16.96
4% of jobs
$16.96 - $22.77
9% of jobs
$25.74 is the 25th percentile. Wages below this are outliers.
$22.77 - $28.58
24% of jobs
The median wage is $33.77 / hr.
$28.58 - $34.39
15% of jobs
$34.39 - $40.20
16% of jobs
$44.12 is the 75th percentile. Wages above this are outliers.
$40.20 - $46.01
11% of jobs
$46.01 - $51.81
10% of jobs
$51.81 - $57.62
8% of jobs
$57.62 - $63.43
0% of jobs
$63.43 - $69.24
2% of jobs
$69.24 - $75.05
2% of jobs
$11
$38
$75
A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.
As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.
To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.
For Trial Master File jobs in Raleigh, NC, the most frequently searched job titles are:
The top searched job categories for Trial Master File jobs in Raleigh, NC are:
Cities near Raleigh, NC with the most Trial Master File job openings:

Raleigh, NC • Hybrid
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 11 days ago
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
About the Role
The Senior Clinical Project Manager, Clinical Development is responsible for leading the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials. The Sr. CPM serves as the operational leader for assigned studies, partnering cross-functionally with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.
Key Responsibilities
Required Skills and Experience
Preferred Qualifications
#LI-Hybrid
#LI-Full-time
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits We Offer:
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