Regulatory and Start Up Specialist

🔥 2 hours ago

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

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

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. • Distribute completed documents to sites and internal project team members. • Prepare site regulatory documents, reviewing for completeness and accuracy. • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

🎯 Requirements

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and 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.

🏖️ Benefits

• Home Based position requiring German language fluency