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Tmf Manager Jobs in Raleigh, NC (NOW HIRING)

Winaxis

Clinical Research Coordinator

Raleigh, NC · On-site

$23.50 - $31.25/hr

... TMF) Regulatory Documentation Adverse Event Reporting Data Management Communication & Coordination Attention to Detail Time Management Benefits Competitive salary Health insurance Performance-based ...

PSI CRO

Site Management Associate I

Durham, NC · On-site

Coordinates preparation for and follow-up on site, TMF and systems' audits and inspections ... Provides training in courier management and study supplies ordering to the site team Document ...

PSI CRO

Site Management Associate I

Durham, NC

Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections ... Provides training in courier management and study supplies ordering to the site team Document ...

IQVIA

Senior Global Clinical Study Manager

Durham, NC · On-site

Maintain TMF health and ensure timely document submission * Develop quality monitoring plans and ... Experience managing global clinical trials and multi-regional teams * Demonstrated experience in ...

IQVIA

Senior Global Clinical Study Manager

Durham, NC · On-site

Maintain TMF health and ensure timely document submission * Develop quality monitoring plans and ... Experience managing global clinical trials and multi-regional teams * Demonstrated experience in ...

PSI CRO

Project Coordination Associate

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 ...

Syneoshealth

CTM - Future Roles (US)

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 ...

Syneos Health

CTM - Future Roles (US)

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 ...

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Tmf Manager information

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How much do tmf manager jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for tmf manager in Raleigh, NC is $60.77, according to ZipRecruiter salary data. Most workers in this role earn between $49.28 and $68.46 per hour, depending on experience, location, and employer.

What is a TMF Manager?

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.

What are the key skills and qualifications needed to thrive as a TMF Manager?

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.

What are some typical challenges a TMF Manager might face in their role?

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.

What are the most commonly searched types of Tmf jobs in Raleigh, NC?

The most popular types of Tmf jobs in Raleigh, NC are:

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For Tmf Manager jobs in Raleigh, NC, the most frequently searched job titles are:

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Tmf Manager jobs near you
Infographic showing various Tmf Manager job openings in Raleigh, NC as of September 2026, with employment types broken down into 81% Full Time, 14% Part Time, and 5% Contract. Highlights an 76% Physical, 2% Hybrid, and 22% Remote job distribution, with an average salary of $126,397 per year, or $60.8 per hour.

Clinical Research Coordinator

Raleigh, NC • On-site

Winaxis
IT Services • 11 - 50 employees
Learn more about Winaxisexternal

$23.50 - $31.25/hr

Full-time

Medical, PTO

Posted 6 days ago

Job description

Job Title : Clinical Research Coordinator (CRC) Experience : 0–3 Years Location : Dallas, Texas Employment Type : Full-time Job Summary:- We are looking for a motivated and detail-oriented Clinical Research Coordinator to support the planning, execution, and management of clinical research studies. The ideal candidate should have 0–3 years of experience in clinical research and a strong understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements. Fresh graduates with relevant internships or clinical research training are encouraged to apply. Key Responsibilities Coordinate and manage clinical research studies in compliance with study protocols, ICH-GCP guidelines, and applicable regulations. Screen, recruit, and enroll study participants. Obtain informed consent from study participants. Schedule and coordinate patient visits and follow-up appointments. Collect, verify, and maintain accurate study documentation and source data. Enter clinical data into Electronic Data Capture (EDC) systems. Maintain Trial Master File (TMF), Investigator Site File (ISF), and essential study documents. Report adverse events and serious adverse events according to protocol and regulatory requirements. Coordinate with investigators, sponsors, CROs, and ethics committees. Prepare for monitoring visits, audits, and regulatory inspections. Ensure protocol compliance and participant safety throughout the study. Assist with study start-up, close-out activities, and regulatory submissions. Required Qualifications Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, or a related field. 0–3 years of experience in clinical research or clinical trial coordination. Knowledge of ICH-GCP, FDA, and local regulatory guidelines. Familiarity with EDC systems and Microsoft Office. Strong organizational, communication, and documentation skills. Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications GCP Certification. Clinical Research certification is an added advantage. Experience with site coordination or patient recruitment. Knowledge of clinical trial documentation and regulatory submissions. Key Skills Clinical Trial Coordination ICH-GCP Compliance Patient Recruitment Informed Consent Process Source Documentation Electronic Data Capture (EDC) Trial Master File (TMF) Regulatory Documentation Adverse Event Reporting Data Management Communication & Coordination Attention to Detail Time Management Benefits Competitive salary Health insurance Performance-based incentives Training and career development opportunities Paid leave and holidays Exposure to global clinical research projects How to Apply Interested candidates can submit their updated resume along with a cover letter highlighting their clinical research experience, certifications, and relevant skills.