Regulatory and Start Up Specialist - Poland
Core
Senior Associate RSU Specialist ensuring efficient site activation and regulatory compliance for clinical trials in Poland.
Role type
Senior Associate Regulatory and Start Up Specialist (Clinical Research)
Builds
Clinical trial start-up and site activation delivery for life sciences sponsors
Domain
Life Sciences / Clinical Research / Healthcare Intelligence
Required skills
Site activation, Regulatory submissions, Clinical Trial Agreements (CTAs) negotiation, Clinical trial start-up activities, Contract negotiation, Local regulatory expertise, Quality review of site documentation, Project milestone tracking, Risk mitigation planning
Preferred skills
Stakeholder management, Continuous process improvement, Multi-priority management
Technologies
Internal tracking systems, Regulatory submission platforms
Responsibilities
Serve as primary point of contact for investigative sites and Site Activation Managers; Coordinate and execute country-specific site activation and regulatory activities; Prepare, review, and distribute regulatory documentation (Ethics Committee submissions, ICFs, Investigator Packs, CTAs); Support contract negotiation activities; Monitor project milestones and identify risks; Provide local regulatory expertise to project teams; Perform quality reviews of site documentation; Review site performance metrics.
Seniority
Senior Associate, hands-on IC
