Reg & Start Up Spec 2
Core
Execute country-level Site Activation (SA) activities for clinical studies, ensuring adherence to local/international regulations, SOPs, and project timelines.
Role type
Senior Site Activation Specialist (Clinical Research)
Builds
Regulatory documents, Investigator Packs, and site activation deliverables for clinical trials
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial regulations (GCP/ICH), Site Activation procedures, Regulatory document preparation, Project planning, Quality control, Database management, Local regulatory expertise
Preferred skills
Leadership experience, Negotiation, Stakeholder management
Technologies
Clinical systems, Databases, Tracking tools
Responsibilities
Serve as Single Point of Contact for assigned studies; Prepare and review site regulatory documents for completeness; Track and follow up on document approvals (ICF, IP); Provide local expertise to project teams; Perform quality control of site documents; Manage project timelines and contingency plans.
Seniority
Senior, hands-on IC
