Project Manager II, Early Phase (Poland)
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 external vendors.
Role type
Senior Clinical Trial Project Manager (Early Phase)
Builds
Clinical trial operations and deliverables for sponsors in dermatology and rheumatology (via careerplan.io/jobs/15-003-2C-F65-project-manager-ii-early-phase-poland)
Domain
Clinical Research / Biopharmaceuticals
Required skills
Clinical trial project management, vendor management, budget control, risk mitigation, stakeholder communication, regulatory compliance (GCP/ICH/FDA), site activation oversight, data management coordination, training matrix management
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 site selection, vendor onboarding, and contract negotiations; monitor and control study budgets and timelines; ensure compliance with GCP, ICH, and local regulations; coordinate with sponsors, clinical sites, and functional departments; manage recruitment performance and develop mitigation plans; oversee quality assurance audits and document filing; provide training to CRAs and support site initiation visits.
Seniority
Senior, hands-on IC with mentorship responsibilities