Project Manager II, Early Phase (Romania)
Core
End-to-end management of Phase I and Phase II clinical trials, ensuring compliance with budgets, timelines, and regulatory standards while coordinating cross-functional teams and vendors.
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, vendor management, budget tracking, risk mitigation, site selection and activation, regulatory compliance (GCP/ICH/FDA), stakeholder communication, data management coordination, clinical monitoring oversight
Preferred skills
Dermatology clinical trial experience, bilingualism (English/French), mentorship capabilities, business development support
Technologies
Microsoft Office Suite, Trial Master File (TMF) systems, eCRF platforms
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 study documentation compliance; Track recruitment performance and develop mitigation plans; Provide training to Clinical Research Associates (CRAs) and support site initiation visits.
Seniority
Senior, hands-on IC with mentorship responsibilities (via careerplan.io/jobs/15-003-2C-F6A-project-manager-ii-early-phase-romania)