eTMF Specialist (Pharmaceutical Clinical)

SRG; Richmond (VA); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading company in the Life Sciences sector is seeking an eTMF Specialist for a long-term remote contract. This role involves managing the electronic Trial Master File to ensure compliance with regulatory standards. Candidates should have substantial experience in the pharmaceutical industry and proficiency with Veeva Vault. The position offers a competitive hourly rate and the opportunity to work with a dynamic clinical research team.

Qualifications

• Minimum 5 years of pharmaceutical industry experience.
• At least 3 years of TMF experience including study start-up and quality reviews.

Responsibilities

• Manage initiation, maintenance, and closure of eTMF systems.
• Ensure documentation aligns with ICH-GCP and FDA standards.
• Provide guidance and training on eTMF procedures.

Skills

Pharmaceutical Industry Experience

TMF Experience

Veeva Vault Proficiency

Quality Assurance

Education

Certification in Clinical Research

Tools

Veeva Vault

Job description

eTMF Specialist (Pharmaceutical Clinical)

Join to apply for the eTMF Specialist (Pharmaceutical Clinical) role at SRG.

This range is provided by SRG. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$38.00/hr - $40.00/hr

SRG, a leader in the Life Sciences human capital industry, is seeking a full-time, contract eTMF Specialist to join our client's pharmaceutical clinical research team. The role involves managing and maintaining the electronic Trial Master File (eTMF) system to ensure regulatory compliance and adherence to company standards.

*12+ month long-term contract; REMOTE

Must Haves

• Minimum 5 years of pharmaceutical industry or drug development experience
• At least 3 years of TMF experience, including study start-up, maintenance, closeout, and quality reviews
• Proficiency with Veeva Vault and extensive experience with this software
• Experience managing EDLs within Veeva Vault
• Conducting quality reviews through Veeva Vault
• Certification in clinical research or eTMF management (preferred)

Job Responsibilities

• eTMF Oversight: Manage initiation, ongoing maintenance, and closure of eTMF systems across studies.
• Regulatory Compliance: Ensure documentation aligns with ICH-GCP, FDA, EMA, and other standards.
• Document Quality Assurance: Perform audits and supervise CROs to ensure inspection readiness and compliance for regulatory submissions.
• Training & Support: Provide guidance and training on eTMF procedures and tools.
• Cross-Functional Coordination: Collaborate with Clinical Operations, Regulatory Affairs, and other teams to ensure integrated eTMF processes.
• Document Management: Lead study-specific eTMF plans, oversee document uploads and organization, and maintain EDLs throughout the study lifecycle.

Only candidates selected for further steps will be contacted by SRG's Recruitment Team. Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. Reasonable accommodations are available upon request.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job functions: Research and Science
• Industries: Pharmaceutical Manufacturing