Project Manager II, Early Phase (Germany)
Core
End-to-end management of Phase I and Phase II clinical trials, ensuring 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 the dermatology domain
Domain
Clinical research / Dermatology
Required skills
Clinical trial project management, budget control, vendor management, risk mitigation, stakeholder communication, regulatory compliance (GCP/ICH/FDA), site activation, data management coordination, training matrix management
Preferred skills
Dermatology clinical trial experience, bilingualism (English/French), mentorship, business development support
Technologies
Microsoft Office Suite, Trial Master File (TMF) systems, eCRF platforms (via careerplan.io/jobs/15-003-2C-F61-project-manager-ii-early-phase-germany)
Responsibilities
Lead study start-up activities including site selection, vendor onboarding, and contract negotiations; monitor and control study budgets and timelines; coordinate cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs; ensure compliance with GCP, ICH, and local regulations; manage recruitment performance and develop mitigation plans; oversee quality assurance audits and document archiving; provide training to CRAs and support site initiation visits.
Seniority
Senior, hands-on IC with mentorship responsibilities