Trial Master File Specialist II – TMF and ALCOA Principles Experience Required

🔥 48 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 18%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Assist with setup and maintenance of the Trial Master File (TMF) • Serve as the main point of contact for TMF-related activities for assigned projects • Process and index project documents in the TMF according to project-specific guidelines and relevant SOPs • Assist with TMF reconciliation upon study closure • Ship files to the client when agreed and prepare the TMF for archiving • Track and quality-check documents using internal systems and ALCOA+ principles • Prepare study team reports or TMF status updates • Support study-specific audit preparations • Attend in-house project audits when required and participate in analysis of audit reports • For TMF Specialist II, propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of the project

🎯 Requirements

• TMF maintenance and quality check experience • Experience with ALCOA Principles • Administrative work experience, preferably in an international Clinical Research setting • Proficiency in Excel • Ability to take responsibility for TMF quality and follow up on topics independently • Very good English oral and written communication skills

🏖️ Benefits

• Remote work option • Work-life balance • Collaborative, international team environment • Career growth opportunities • Trusted ownership and flexibility • Opportunity to work with experts in clinical research, pharmacovigilance, and quality consulting

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