(Sr) Project Manager, Feasibility Site Activation
Core
Drive the successful start-up of global clinical studies by owning the Study Start-Up (SSU) strategy and execution to ensure efficient site activation and regulatory compliance.
Role type
Senior IC Project Manager (Clinical Study Start-Up)
Builds
Global clinical studies and multi-country study start-ups
Domain
Healthcare / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study Start-Up (SSU) strategy execution, end-to-end site activation, regulatory and ethics submission management, site contract and budget negotiation, risk and dependency management, CTMS and eTMF system oversight, ICH-GCP framework knowledge
Preferred skills
Bid defense and kick-off meeting facilitation, cross-functional team leadership, process improvement initiatives, stakeholder management across sponsors and sites
Technologies
CTMS, eTMF
Responsibilities
Shape and execute SSU strategies for global studies, lead development of SSU Plans covering regulatory and contract execution, drive activities from site identification to IP release, provide strategic input on study design feasibility, oversee regulatory and ethics submissions, manage site contract negotiations, identify and mitigate risks, coordinate SSU team members, ensure documentation accuracy and inspection readiness, maintain oversight of study metrics and budgets
Seniority
Senior, hands-on IC
