Senior Project Manager, Early Phase and Translational Research (USA)
Core
Oversees and manages domestic, regional, and international clinical trials (Phase I-III) for drug development, ensuring successful initiation, planning, execution, monitoring, and closure.
Role type
Senior Project Manager, Early Phase and Translational Research
Builds
Clinical trials and associated project deliverables
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical trial project management, budget management, risk mitigation, stakeholder communication, team leadership, regulatory compliance (GCP/ICH), vendor management, site activation, data management oversight, recruitment management, quality assurance, training development (via careerplan.io/jobs/15-003-33-278-senior-project-manager-early-phase-and-translational-research-usa-at-indero)
Preferred skills
PMP certification, cost management, study start-up, regulatory submission, resource management, supervisory experience, CRA experience, data management, medical writing, vendor management, dermatology therapeutic experience
Technologies
Microsoft Office suite
Responsibilities
Serve as primary contact for sponsors, sites, CRAs, and vendors; manage project timelines, budgets, and resources; lead study start-up processes including site selection and activation; monitor study quality and compliance; mentor team members; prepare presentations for new business; oversee clinical monitoring activities; manage recruitment status and mitigate slippage.
Seniority
Senior, hands-on IC with mentorship responsibilities