TMF Specialist (FSP)

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

• Support Trial Master File (TMF) set-up, maintenance, update, archival and closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations.
• Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving.
• Conduct detailed and appropriate quality checks (QC) on TMF documents at defined time points, including any paper originals required.
• Ensure that privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with retention practices.
• Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines.
• Other duties as assigned.

Necessary Skills and Abilities:

• Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Exhibits a good understanding of general quality assurance concepts and practices.
• Highly organized with a strong attention to detail.
• Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.).