Project Manager II, Early Phase (Poland)
Core
End-to-end management of Phase I and II clinical trials, overseeing initiation, planning, execution, monitoring, and closure to ensure compliance with budgets, timelines, and regulatory standards.
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-at-indero)
Domain
Clinical research / Dermatology / Rheumatology
Required skills
Clinical trial project management, vendor management, budget tracking, risk mitigation, site selection and activation, regulatory compliance (GCP/ICH/FDA), stakeholder communication, quality assurance, data management coordination, clinical monitoring oversight
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, vendor onboarding, and budget negotiations; Monitor and control study budgets by tracking hours and managing change orders; Coordinate cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs; Ensure compliance with GCP, ICH, and local regulations; Track recruitment performance and develop mitigation plans; Provide project-specific training to CRAs and support site initiation visits; Oversee quality of project deliverables and TMF maintenance.
Seniority
Senior, hands-on IC