Senior Project Manager, Early Phase and Translational Research (USA)
Core
Oversees and manages domestic, regional, and international clinical trials (Phase I-III) for sponsors, ensuring successful initiation, planning, execution, monitoring, and closure while mitigating risks and meeting client expectations.
Role type
Senior Project Manager (Clinical Trials)
Builds
Clinical trial studies for pharmaceutical sponsors
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical trial project management, risk management, budget control, stakeholder communication, team leadership, regulatory compliance (GCP/ICH), vendor management, site activation, data management oversight, quality assurance, recruitment management (via careerplan.io/jobs/15-003-33-278-senior-project-manager-early-phase-and-translational-research-usa)
Preferred skills
PMP certification, cost management, study start-up, resource management, supervisory experience, CRA experience, data management, medical writing, vendor management, dermatology therapeutic area
Technologies
Microsoft Office suite
Responsibilities
Lead study start-up process including kick-off meetings, TMF setup, site selection, and vendor contracting; Manage project budgets, timelines, and resources; Ensure studies are audit-ready and compliant with GCP/regulatory requirements; Mentor project managers and contribute to continuous improvement; Coordinate with sponsors, CRAs, vendors, and internal teams; Monitor recruitment status and mitigate slippage; Prepare presentations for new business development.
Seniority
Senior, hands-on IC with mentorship responsibilities