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.
Senior Associate I, TMF Operations
🕒 April 17
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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
• Perform RMC Lead Activities for 1-3 Studies • Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project Teams (PT) and eTMF administrators • Review eTMF access and coordinate updates, as necessary • Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF • Oversee the QC process and make sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly • Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors • Review TMF Key Performance Indicators (KPIs) and ensure that TMF KPIs are in compliance • Support Regulatory and Sponsor audits and audits finding resolution, where necessary
🎯 Requirements
• University Degree preferred (Life Science desirable) • 1-3 years of relevant experience • Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Industry • Excellent written and verbal communication skills • Strong interpersonal skills • Ability to handle multiple, highly detailed tasks with exceptional accuracy • Strong planning and organizational skills • Proficiency in Microsoft Word and Excel
🏖️ Benefits
• Health insurance • Professional development opportunities • Flexible working hours • Remote work options
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