Regulatory and Start Up Specialist
Core
Ensure timely and quality site activation readiness for clinical trials by managing regulatory submissions, ethics committee interactions, and site contract/budget negotiations in the UK.
Role type
Senior Regulatory and Start Up Specialist (Clinical Trials)
Builds
Clinical trial authorizations and site activation for oncology and rare disease studies
Domain
Clinical Research Organization (CRO) / Life Sciences
Required skills
Regulatory submission preparation, Competent Authority/Ethics Committee interaction, site contract negotiation, budget negotiation, site activation planning, document translation coordination, local clinical trial law knowledge, TMF management
Preferred skills
Pharmacy qualification or Pharmacist experience, site feasibility assessment, milestone tracking tools, advanced degree in medical/life sciences, RAC certification, Masters in Regulatory Science
Technologies
Computerized information systems, electronic spreadsheets, word processing, electronic mail, milestone tracking tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers; interact with Competent Authorities and Ethics Committees; negotiate investigator contracts and study budgets; customize Patient Information Sheets and Informed Consent Forms; coordinate document translations; maintain audit/inspection readiness; support Pre-Study Site Visits; act as SME for site activation critical path data.
