TMF Associate

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Establish and maintain Trial Master Files (TMFs) according to company procedures and regulatory requirements • Develop and maintain study-specific TMF Plans • Provide TMF-related training to study teams • Perform document quality control reviews and reconciliation activities • Monitor TMF metrics and identify quality or compliance issues • Drive resolution activities for quality or compliance issues • Prepare and distribute monthly TMF status reports to project and functional leadership • Coordinate TMF reconciliation activities and support document transfers to sponsors • Ensure TMFs remain submission-, inspection-, and audit-ready throughout the study lifecycle • Serve as the primary TMF contact for study teams • Participate in study team meetings and provide updates on TMF quality and status • Support audits, inspections, and quality improvement initiatives • Set up and maintain Investigator Site Files (ISFs) when required

🎯 Requirements

• Bachelor's degree in Health Sciences, Document Management, or a related field, or equivalent work experience • 1–2 years of experience working with TMF • Knowledge of ICH-GCP guidelines and TMF requirements • Strong organizational and multitasking skills • Keen attention to detail • Excellent written and verbal communication skills • Home-based in Poland

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Home-based/fully remote work arrangement

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