Trial Master File Specialist II – TMF, ALCOA Principles

Job not on LinkedIn

🔥 32 minutes ago

🇧🇦 Bosnia and Herzegovina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 18%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 in the TMF according to project-specific guidelines and relevant SOPs • Assist with TMF reconciliation upon study closure • Ship files to the client, if agreed, and prepare the TMF for archiving • Track and quality-check documents using internal systems and ALCOA+ principles • Prepare study team reports or updates regarding TMF status • Support preparations for study-specific audits • Attend in-house project audits when required • Participate in analysis of received audit reports • 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 • Ability to follow up on topics independently • Very good English oral and written communication skills

🏖️ Benefits

• Remote work availability • Work-life balance • Career growth opportunities • Collaborative international team environment • Opportunity to make an impact on patient care • Supportive workplace culture • Passionate and collaborative team of experts • Belonging and inclusive environment