TMF Masterfile Specialist II — Quality & Compliance

Ergomed; Województwo mazowieckie; On-site; PLN 85,000 - 110,000; Full time

Job summary

Ergomed is hiring a TMF Specialist II to support the Trial Master File lifecycle within an international clinical research setting. You will manage TMF setup and maintenance, serve as the primary TMF contact for projects, and ensure documents are processed and indexed per SOPs.

You will also reconcile TMF at study closure, perform quality checks, and assist in audits and CAPA activities to uphold data integrity and regulatory compliance.

Qualifications

• TMF maintenance and quality check experience.
• ALCOA Principles knowledge.
• Administrative work experience, preferably in an international Clinical Research setting.
• Proficiency in Excel.
• Very good English oral and written communication skills.

Responsibilities

• Assist with set up and maintenance of the Trial Master File (TMF).
• Serve as main point of contact for TMF-related activities on assigned projects.
• Processing and indexing of project documents for the TMF in accordance with project-specific guidelines and relevant SOPs.
• Assist in reconciliation of TMF after study closure; ship files to client and prepare TMF for archiving.
• Track and perform quality check of documents using internal systems and ALCOA+ principles.
• Prepare study team reports or updates regarding TMF status as required.
• Support preparations for study-specific audits and participate in internal audits; assist in analyzing audit reports; propose and oversee CAPA for TMF aspects.

Skills

TMF maintenance

ALCOA principles

English communication

Administrative work experience

Tools

Excel

Job description

Ergomed is hiring a TMF Specialist II to support the Trial Master File lifecycle within an international clinical research setting. You will manage TMF setup and maintenance, serve as the primary TMF contact for projects, and ensure documents are processed and indexed per SOPs.

You will also reconcile TMF at study closure, perform quality checks, and assist in audits and CAPA activities to uphold data integrity and regulatory compliance.