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

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🔥 48 minutes ago

🇭🇷 Croatia – 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 on assigned projects • Process and index project documents according to project-specific guidelines and relevant SOPs • Assist with TMF reconciliation upon study closure • Ship files to the client when agreed • Prepare the TMF for archiving • Track documents and perform quality checks using internal systems and ALCOA+ principles • Prepare study team reports or updates on TMF status • Support preparations for study-specific audits • Attend in-house project audits when required • Participate in analysis of received audit reports • For TMF Specialist II, propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of the project

🎯 Requirements

• Experience maintaining and quality-checking Trial Master Files (TMF) • Experience with ALCOA principles • Administrative work experience, preferably in an international Clinical Research setting • Proficiency in Excel • Ability to take responsibility for TMF quality • Ability to follow up on topics independently • Very good English oral and written communication skills

🏖️ Benefits

• Remote work option • Work-life balance • Career growth opportunities • Collaborative international team environment • Trusted ownership and flexibility • Passionate and collaborative team of experts • Supportive workplace culture

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