Associate II, TMF Operations

🕒 April 17

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

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 and/or TMF QC Reviewer roles as defined by relevant SOPs • Process, review, and resolve rejected TMF documents for complex studies • Prepare periodic TMF Quality Control checklists for Project Team review • Perform TMF Quality Control to ensure adherence to regulatory and industry best practices • Work with Electronic Document Management and eTMF Systems to review Essential Documents

🎯 Requirements

• Minimum 6 months of administrative experience, preferably in the CRO or Pharma industry • Knowledge of working within a highly regulated industry (desirable) • Strong long-term interest in administrative-focused work, with attention to detail • Strong skills in data collection, indexing, and editing • Excellent written and verbal communication skills • Strong interpersonal skills in a fast-paced, deadline-oriented environment • Proficiency in Microsoft Word and Excel

🏖️ Benefits

• Culture of collaboration and innovation • Diverse and inclusive environment • Professional development opportunities

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