Study Start Up Manager - IQVIA Biotech
Core
Direct and manage the delivery of site activation, maintenance, and regulatory activities for clinical studies and multi-protocol programs.
Role type
Senior Study Start-Up Manager
Builds
Clinical trial site activation and maintenance programs
Domain
Life sciences / Clinical research
Required skills
Regulatory strategy, site activation management, budget and resource oversight, contract negotiation, regulatory intelligence, GCP/ICH guidelines application, clinical trial environment knowledge, financial management, multi-regional program oversight
Preferred skills
Mentorship, technical writing, presentation skills, system proficiency (CTMS)
Technologies
CTMS, tracking tools, project management databases
Responsibilities
Oversee site activation and maintenance execution, develop and maintain management plans, provide regulatory and technical support for business development, determine regulatory strategies for submissions, mentor colleagues, manage study budgets, negotiate contracts
Seniority
Senior, hands-on IC
