Project Manager II, Early Phase (Romania)
Core
End-to-end management of Phase I and Phase II clinical trials, ensuring compliance with GCP, regulatory requirements, and study timelines while coordinating resources, vendors, and clinical sites.
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, 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, Trial Master File (TMF) systems, eCRF platforms
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 with sponsors, clinical sites, and functional departments to ensure trial progress; Oversee quality of project deliverables and ensure compliance with SOPs and regulatory requirements; Track recruitment performance and develop mitigation plans; Provide project-specific training to Clinical Research Associates (CRAs) and conduct site initiation visits for single-site studies; Participate in Investigator Meetings and ethics submissions; Mentor junior staff and support process improvement initiatives.
Seniority
Senior, hands-on IC with mentorship responsibilities (via careerplan.io/jobs/15-003-2C-F6A-project-manager-ii-early-phase-romania-at-indero)