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Remote Trial Master File Specialist Jobs in Raleigh, NC

Adecco

Clinical Trials Manager- Remote

Chapel Hill, NC · Remote

$62 - $64.73/hr

Remote Schedule: Full-Time | Eastern Time Zone Hours Pay: $62.00-$64.73 per hour Position Overview ... Support development and maintenance of the Trial Master File (TMF) and ensure document quality and ...

IQVIA

Clinical Trial Rater

Durham, NC · Remote

Clinical Trial Rater - Borderline Personality Disorder (BPD) Location ... Remote based in the US Hours: Approximately 5h per week Role: Clinical Specialist Start: immediate ...

IQVIA

Clinical Trial Rater

Raleigh, NC · Remote

Clinical Trial Rater - Borderline Personality Disorder (BPD) Location ... Remote based in the US Hours: Approximately 5h per week Role: Clinical Specialist Start: immediate ...

Danaher

Principal Clinical Scientist

Raleigh, NC · On-site +1

This role is responsible for clinical trial strategies within the US and EU regions for Danaher ... Author and review clinical and regulatory documentation-including study reports, technical files ...

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Remote Trial Master File Specialist information

What is a remote trial master file specialist?

A Remote Trial Master File (TMF) Specialist is a professional responsible for managing and maintaining the documentation and records related to clinical trials, typically for pharmaceutical or biotech companies, while working from a remote location. They ensure that all essential documents are complete, accurate, and compliant with regulatory standards such as Good Clinical Practice (GCP). Their work is crucial for supporting audits, inspections, and the overall integrity of clinical trial data.

What are the key skills and qualifications needed to thrive as a remote trial master file specialist?

To thrive as a Remote Trial Master File (TMF) Specialist, you need a strong understanding of clinical trial documentation, regulatory compliance, and quality management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF systems (eTMF), document management software, and Good Clinical Practice (GCP) guidelines is typically required. Attention to detail, organization, and effective communication are vital soft skills for managing large volumes of sensitive data and collaborating with cross-functional teams. These skills ensure clinical trial documentation is complete, audit-ready, and compliant with regulatory standards, which is critical for successful study outcomes.

What are the common challenges faced by a remote trial master file specialist, and how can they be addressed?

A Remote TMF Specialist often faces challenges related to maintaining document quality, ensuring timely updates, and coordinating with geographically dispersed teams. Managing secure data access and upholding regulatory compliance standards while working remotely can also be complex. These challenges can be addressed by implementing robust digital TMF systems, establishing clear communication protocols, and participating in regular cross-functional meetings to stay aligned with stakeholders. Staying proactive in learning about regulatory changes and utilizing collaboration tools can further help ensure smooth document management and compliance.

What is the difference between Remote Trial Master File Specialist vs Remote Clinical Data Coordinator?

AspectRemote Trial Master File SpecialistRemote Clinical Data Coordinator
CertificationsICH GCP, regulatory document managementICH GCP, data management certifications
Work EnvironmentClinical trial documentation, regulatory complianceData entry, database management
Industry UsagePharmaceutical, biotech, CROsPharmaceutical, biotech, CROs

The Remote Trial Master File Specialist primarily manages and maintains regulatory documents for clinical trials, ensuring compliance and proper filing. The Remote Clinical Data Coordinator focuses on managing clinical trial data, including data entry and validation. While both roles support clinical research, the Trial Master File Specialist emphasizes document management, whereas the Data Coordinator concentrates on data accuracy and database oversight.

What are popular job titles related to Remote Trial Master File Specialist jobs in Raleigh, NC?

For Remote Trial Master File Specialist jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Remote Trial Master File Specialist jobs in Raleigh, NC look for?

The top searched job categories for Remote Trial Master File Specialist jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Remote Trial Master File Specialist jobs?

Cities near Raleigh, NC with the most Remote Trial Master File Specialist job openings:

Remote Trial Master File Specialist jobs near you
Infographic showing various Remote Trial Master File Specialist job openings in Raleigh, NC as of August 2026, with employment types broken down into 91% Full Time, and 9% Part Time. Highlights an 100% Remote job distribution.

Clinical Trials Manager- Remote

Chapel Hill, NC • Remote

Adecco
Recruiting and Staffing Services • 10K+ employees
Learn more about Adeccoexternal

$62 - $64.73/hr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 18 days ago

Job description

Clinical Trials Manager (CTM)

Location: Remote
Schedule: Full-Time | Eastern Time Zone Hours
Pay: $62.00–$64.73 per hour

Position Overview

We are seeking an experienced Clinical Trials Manager (CTM) to oversee the clinical operational and quality aspects of assigned clinical studies. This role is responsible for ensuring clinical deliverables are completed on time, within scope, and to quality standards, while supporting patient recruitment, study performance, and overall trial execution.

The ideal candidate will have strong clinical operations experience, excellent leadership and organizational skills, and a solid understanding of ICH/GCP, FDA regulations, clinical monitoring, and patient recruitment strategies.

Key Responsibilities

  • Manage clinical operational and quality activities for assigned studies in compliance with ICH/GCP and applicable regulations.

  • Develop and maintain clinical tools, monitoring plans, guidelines, and study documentation.

  • Support development and maintenance of the Trial Master File (TMF) and ensure document quality and completeness.

  • Collaborate with Project Managers, clinical teams, data management, and other departments to meet study deliverables.

  • Lead clinical team meetings and ensure timelines, resources, communication, and quality objectives are maintained.

  • Monitor clinical timelines, metrics, site performance, and study progress.

  • Review monitoring reports, oversee CRF collection and query resolution, and implement recovery actions when needed.

  • Support patient recruitment strategies and work with study sites to address recruitment and retention challenges.

  • Communicate with study sites regarding protocol requirements, patient participation, CRFs, and study-related issues.

  • Coordinate study start-up activities and support timely ethics committee and regulatory submissions.

  • Ensure essential documents meet regulatory and quality requirements.

  • Support clinical resource planning, delegation of responsibilities, and identification of additional staffing needs.

  • Provide regular project status updates and contribute to client meetings and presentations.

  • Support forecasting, budgeting, and management of clinical project resources.

  • Ensure timely archiving of study documents and materials.

Qualifications

  • Bachelor's degree or equivalent relevant education.

  • 5+ years of relevant clinical research/clinical operations experience or comparable experience.

  • Strong understanding of ICH/GCP, FDA guidelines, and clinical trial requirements.

  • Experience with clinical monitoring practices and study operations.

  • Demonstrated experience with patient recruitment and retention strategies.

  • Strong leadership, mentoring, and team-building skills.

  • Excellent planning, organization, and prioritization abilities.

  • Strong problem-solving, judgment, and decision-making skills.

  • Ability to work effectively in a multicultural, matrixed, and changing environment.

  • Strong written and verbal communication skills.

  • Excellent attention to detail and ability to manage multiple priorities.

  • Working knowledge of Outlook, Excel, Word, and clinical research systems.

  • Understanding of budgeting, forecasting, resource allocation, and financial management preferred.

Work Arrangement

  • 100% Remote

  • Must be available to work Eastern Time Zone hours.

  • Full-time position.

Pay Rate: $62.00–$64.73/hour


Pay Details: $62.00 to $64.73 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.