Team Lead, TMF Operations

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Responsible for maintaining Trial Master Files inspection readiness in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. • Drive the delivery of Project Team objectives in ensuring the management of the essential documents. • Facilitate the delivery of TMF Services for 5-10 studies • Monitor Key Performance Indicators and communicate performance to Project Teams (PT) and Sponsors • Identify key risks and mitigate risks • Analyze and interpret data to make informed data driven decisions • Develop project specific Quality Management Documents (QMDs)

🎯 Requirements

• University Degree preferred (Life Science desirable) • Combination of education plus 3-5 years of relevant experience • In depth knowledge of ICH GCP • Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.) • Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.) • Working knowledge of working within highly regulated industries (desirable)

🏖️ Benefits

• We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.