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Trial Master File Associate Jobs in Raleigh, NC (NOW HIRING)

System One

Clinical Study Manager

Durham, NC · On-site

... Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. • Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. • Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. • Draft, review, and/or approve study-related documents, including ...

IQVIA

Clinical Research Associate

Durham, NC

$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 ...

System One

Clinical Study Manager

Durham, NC · On-site

... Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. • Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. • Draft, review, and/or approve study-related documents, including ...

IQVIA

Clinical Research Associate

Durham, NC

$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 ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in CNS, GLP-1 ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC · On-site

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in CNS, GLP-1 ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Syneoshealth

CTM - Future Roles (US)

Morrisville, NC · On-site

Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ... For Real World Late Phase, the CRA I will use the business card title of Site Management Associate ...

Syneos Health

CTM - Future Roles (US)

Morrisville, NC · On-site

Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ... For Real World Late Phase, the CRA I will use the business card title of Site Management Associate ...

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
What are the most commonly searched types of Trial Master File jobs in Raleigh, NC? The most popular types of Trial Master File jobs in Raleigh, NC are:
What are popular job titles related to Trial Master File Associate jobs in Raleigh, NC? For Trial Master File Associate jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Raleigh, NC look for? The top searched job categories for Trial Master File Associate jobs in Raleigh, NC are:
Trial Master File Associate jobs near you
Clinical Study Manager in Durham, NC

Clinical Study Manager in Durham, NC

Intellectt INC

Durham, NC • On-site

$56/hr

Contractor

Posted 8 days ago

Job description

Location- Durham, NC
The Contract Clinical Study Manager provides operational leadership, coordination, and oversight for assigned clinical studies. This role supports the successful execution of study activities in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and study-specific plans. The Contract Clinical Study Manager works closely with internal cross-functional teams, CROs, vendors, investigators, and study site personnel to ensure study deliverables are completed with quality, within expected timelines, and in alignment with study objectives.
 
Primary Responsibilities
• Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out.
• Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Monitor adherence to essential document collection processes, site activation requirements, clinical supply release requirements, and study-specific tracking tools.
• Support and/or lead meetings with CROs, vendors, and cross-functional teams to review study progress, risks, issues, action items, and deliverables.
• Track and support development of study-specific timelines, deliverables, and mitigation plans to address study delays or operational risks.
• Assist in vendor selection activities, including contribution to RFPs, scopes of work, vendor budgets, and study/vendor-specific planning documents.
• Evaluate CRO and vendor performance and support early identification, escalation, mitigation, and resolution of potential issues.
• Develop, implement, and follow up on corrective and preventive action plans, as appropriate.
• Coordinate and verify study-specific training for CRO staff, vendors, investigators, study coordinators, and other relevant study team members.
• Support oversight of vendor staff qualification, training, turnover documentation, and ongoing performance against study milestones and KPIs.
• Assist in the management and maintenance of the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities.
• Draft, review, and/or approve study-related documents, including informed consent forms, site worksheets, vendor/site manuals, pharmacy manuals, laboratory manuals, monitoring plans, and monitoring reports, as applicable.
• Review and support responses to site audits, monitoring findings, and other escalated study conduct issues.
• Provide clinical and operational responses to study centers, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating issues when appropriate.
• Ensure study documentation supports inspection readiness and compliance with applicable regulatory requirements, company SOPs, and study protocols.
• Oversee CTMS tracking and study status reporting to support evaluation and management of study set-up, conduct, follow-up, and close-out activities.
• Review clinical data, data listings, vendor reports, monitoring trends, and other study outputs to support data integrity and GCP compliance.
• Provide clinical input into case report forms, data management plans, data transfer plans, and clinical data review activities.
• Collaborate with data management, safety, regulatory, clinical supplies, contracts, biostatistics, and other functional groups to support study execution.
• Prepare key reports on study progress, risks, issues, action items, and delegated clinical study management responsibilities.
• Provide input into study, site, and vendor budgets, as needed.
• Review site and vendor invoices to ensure expenses are consistent with work performed, approved budgets, and study agreements.
• Support investigator budget templates, vendor scopes of work, contract-related inputs, and study financial tracking activities.
• Managers and supervisors may assign other duties as needed.
 
Required Knowledge, Skills, and Abilities
• Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities.
• Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company SOPs.
• Demonstrated ability to manage CROs, vendors, study timelines, risks, action items, and cross-functional deliverables.
• Ability to identify issues, evaluate options, make sound recommendations, and drive timely resolution.
• Strong verbal, written, organizational, and interpersonal communication skills.
• Ability to manage competing priorities, work independently, and collaborate effectively with internal and external stakeholders.
• Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools.
 
Education and Experience
• Bachelor’s degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered.
• At least eight years of clinical research experience, including at least two years of experience in clinical study management, clinical operations, or related clinical trial roles.
• Experience working with CROs, vendors, clinical sites, and cross-functional study teams is required.
• Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation is preferred.
 
M-F, 1st shift - hybrid - 3 days in office in RTP