IQVIA UK is seeking a Regulatory and Start-Up Specialist in São Paulo, Brazil, to manage regulatory and site activation activities for clinical research studies. The ideal candidate should have a background in life sciences, experience in a regulatory role within a CRO or pharma, and strong communication skills
Job Summary
Executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.
Prepares and manages site documentation, reviews and negotiates site documents and contracts, and serves as the primary point of contact for investigative sites.
Updates and maintains internal systems, databases, tracking tools, timelines, and project plans with accurate project-specific information.
Matching Summary
Match Score: 85
IQVIA UK is seeking a Regulatory and Start-Up Specialist in São Paulo, Brazil, to manage regulatory and site activation activities for clinical research studies. The ideal candidate should have a background in life sciences, experience in a regulatory role within a CRO or pharma, and strong communication skills.
Skills & Requirements
Must-have
Site identification and feasibility
Regulatory and start-up execution
Site documentation preparation and management
Contract negotiation with sites and sponsors
Primary point of contact for investigative sites
Tracking and reporting site performance metrics
Nice-to-have
Advanced knowledge within a specific discipline
Great communication and teamwork skills
Key Requirements
Bachelor's Degree Life sciences or related field
1-2 years experience in regulatory role at CRO or pharma
Experience with CEP/CONEP submissions and amendments