Associate I, TMF Operations – Fixed Term

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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

• Fulfil the "TMF Approver" role as defined by the relevant SOP • Process, review, and resolve rejected Trial Master File (TMF) documents • Work with various Electronic Document Management and electronic TMF Systems • Communicate directly with RMC Lead to report trends and issues • Escalate any TMF Quality issues in a timely manner to RMC Lead • Provide administrative support including filing and maintaining internal documents • Perform additional tasks as assigned by the Line Manager

🎯 Requirements

• Possess data collection, indexing and editing skills • Possess excellent written and verbal communication skills • Work with internal teams and can execute tasks under general direction • Exercise sound judgment and ability to identify decisions requiring supervisory approval • Demonstrate proficiency in Microsoft Word and Excel • Develop proficiency in use of an electronic document repository or eTMF • General understanding of clinical research principles and processes • University Degree preferred • Minimum 6 months of relevant TMF experience • Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)

🏖️ Benefits

• Inclusive environment that promotes collaboration and creativity • Training and development opportunities