Regulatory and Start Up Specialist

🔥 38 minutes ago

🇬🇧 United Kingdom – Remote

💵 £33.7k - £61.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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 • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments • 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 • Review and provide feedback to management on site performance metrics • Review, establish and agree on project planning and project timelines • Ensure monitoring measures are in place and implement contingency plan as needed • Inform team members of completion of regulatory and contractual documents for individual sites • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines • Provide local expertise to SAMs and project team during initial and on-going project timeline planning • Perform quality control of documents provided by sites.

🎯 Requirements

• Bachelor’s Degree in life sciences or a related field • 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 • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

🏖️ Benefits

• Employee Referral Payment • Standard Referral Bonus Plan