TMF Specialist - Quality & Document Control

ProPharma; Bedford (MA); On-site; USD 55,000 - 85,000; Full time

Job summary

ProPharma is seeking a Quality Assurance/ TMF Specialist to support trial master file setup, maintenance, update, archival and closeout per SOPs and sponsor regulations. The role includes document review, metadata management, and ensuring compliance with privacy, security, and retention practices.

Responsibilities include detailed QC at defined time points, audits support, and collaboration with internal and external stakeholders using web-based systems and project management tools.

Qualifications

• Effective communication and interpersonal skills for cross-functional collaboration.
• Ability to prioritize multiple tasks and follow defined instructions.
• Understanding of quality assurance concepts and practices.
• Highly organized with strong attention to detail.
• Proficiency in web-based systems and project management tools (e.g., MS Office, SharePoint).

Responsibilities

• Support TMF set-up, maintenance, update, archival and closeout in line with SOPs and sponsor/regulatory requirements.
• Review, edit and format master documents, manage metadata, monitor status, distribute and archive.
• Perform detailed QC on TMF documents at defined points, including paper originals if needed.
• Ensure privacy and security standards and retention practices are followed.
• Assist in routine internal and external master file audits for compliance with SOPs, regulations and ICH/GCP.

Skills

Effective communication

Prioritization

Quality assurance

Attention to detail

Project management tools

Tools

Microsoft Office

SharePoint

Job description

ProPharma is seeking a Quality Assurance/ TMF Specialist to support trial master file setup, maintenance, update, archival and closeout per SOPs and sponsor regulations. The role includes document review, metadata management, and ensuring compliance with privacy, security, and retention practices.

Responsibilities include detailed QC at defined time points, audits support, and collaboration with internal and external stakeholders using web-based systems and project management tools.