Regulatory and Start Up Specialist

🔥 0 minutes ago

🇮🇱 Israel – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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IQVIA

WebsiteLinkedInAll Job Openings

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, quality of deliverables 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 • 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 • Track and follow up on regulatory, ethics, ICF and Investigator Pack release documents • Provide local expertise to SAMs and project teams during project timeline planning • Perform quality control of documents provided by sites • May have direct contact with sponsors on specific initiatives

🎯 Requirements

• Home Based position requiring Hebrew language fluency • 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, local regulations, SOPs and company’s Corporate Standards • Understanding of regulated clinical trial environment and knowledge of drug development process