Study Start Up Specialist
Core
Coordinates and oversees site activations for clinical trials, ensuring compliance with protocols, ICH-GCP, and regulatory requirements while acting as the primary point of contact for sponsors.
Role type
Senior Clinical Trial Study Start-Up Specialist
Builds
Site initiation and activation for oncology and rare disease clinical trials
Domain
Clinical Research / Oncology / Rare Disease
Deliverable
client delivery
Required skills
ICH-GCP knowledge, regulatory document management, contract negotiation, site feasibility assessment, project budget monitoring, team mentorship
Preferred skills
Multi-country project management, proposal development, SOP implementation
Technologies
Trial Master File (TMF), Informed Consent Forms (ICF), Institutional Review Board (IRB) systems
Responsibilities
Develop start-up strategies and coordinate regulatory deliverables; manage contract negotiations with investigative sites; collect and review essential documents for site activation; support feasibility studies and site identification; monitor project budgets and escalate overruns; mentor department staff.
Seniority
Senior, hands-on IC with management responsibilities
