Project Manager II, Early Phase (Bulgaria)
Core
End-to-end management of early-phase (Phase I/II) clinical trials, ensuring compliance with GCP, regulatory requirements, and study timelines/budgets.
Role type
Senior clinical trial project manager (early phase)
Builds
Clinical trial operations and deliverables for biotech and pharmaceutical sponsors
Domain
Clinical research / Dermatology
Required skills
Clinical trial project management, GCP/ICH/FDA regulatory knowledge, budget management, vendor management, risk mitigation, stakeholder communication, site selection and activation, data management coordination, training matrix development
Preferred skills
Dermatology clinical trial experience, bilingualism (English/French), mentoring junior staff, business development support
Technologies
Microsoft Office Suite
Responsibilities
Lead study start-up activities including kick-off meetings, TMF setup, site selection, and vendor onboarding; Monitor and control study budgets by tracking hours and managing change orders; Coordinate with sponsors, clinical sites, and functional departments to ensure trial progress; Oversee quality assurance audits and ensure TMF compliance; Track recruitment performance and develop mitigation plans; Provide project-specific training to CRAs and support CRA monitoring activities.
Seniority
Senior, hands-on IC