Study Start Up Specialist

🔥 1 hour ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🇬🇧 UK Skilled Worker Visa Sponsor

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Logo of IQVIA

IQVIA

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments • Ensure adherence to SOPs, Work Instructions, deliverable quality, and project timelines • Perform start-up and site activation activities according to regulations, SOPs, and work instructions • Distribute completed documents to sites and internal project team members • Prepare site regulatory documents and review them for completeness and accuracy • Complete and maintain internal systems, databases, and tracking tools with project-specific information • Review site performance metrics and provide feedback to management • Review, establish, and agree on project planning and timelines • Ensure monitoring measures are in place and implement contingency plans as needed • Inform team members of completion of regulatory and contractual documents for individual sites • Review, track, and follow up on regulatory, ethics, ICF, and IP release documents • Provide local expertise to SAMs and project teams during project timeline planning • Perform quality control of documents provided by sites • Maintain activities as required • Have direct contact with sponsors on specific initiatives

🎯 Requirements

• Bachelor’s Degree in life sciences or a related field • 3 years clinical research experience • In-depth knowledge of clinical systems, procedures, and corporate standards • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines • Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards • Understanding of regulated clinical trial environment and knowledge of drug development process • In-depth knowledge of UK clinical trial landscape and submissions

🏖️ Benefits

• Home Based opportunity • Full-time employment

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