Study Start Up Specialist - UK IQVIA Biotech
Core
Execute country-level site activation and regulatory document management for clinical trials in the UK.
Role type
Clinical Trial Site Activation Specialist
Builds
Clinical trial sites and regulatory documentation packages
Domain
Life Sciences / Clinical Research
Required skills
UK clinical trial landscape knowledge, GCP/ICH compliance, regulatory document preparation, site activation procedures, internal system maintenance, project timeline management, quality control of site documents
Preferred skills
Experience with Investigator Pack (IP) and Informed Consent Form (ICF) release, contingency planning, direct sponsor contact
Technologies
Clinical trial databases, internal tracking tools, regulatory submission systems
Responsibilities
Serve as Single Point of Contact for investigative sites; prepare and review site regulatory documents for completeness and accuracy; track and follow up on document approvals and execution; ensure accurate completion of internal systems and databases; review site performance metrics; implement monitoring measures and contingency plans.
Seniority
Mid-level, hands-on IC
