Global Study Lead
Core
Lead and coordinate cross-functional clinical study teams to ensure progress against timelines, budget, and quality standards for pharmaceutical R&D studies.
Role type
Senior clinical study lead (pharmaceutical R&D)
Builds
Clinical studies (non-drug process improvements)
Domain
Pharmaceutical industry + Clinical Research
Deliverable
client delivery
Required skills
Clinical study management, Project management, Team leadership, Regulatory compliance knowledge, Budget management, Risk management, Quality assurance oversight, Stakeholder communication, Strategic thinking
Preferred skills
Mentorship, Process improvement leadership
Technologies
CTMS, eTMF, IXRS, ePRO, Data flow metrics dashboards
Responsibilities
Coordinate cross-functional study teams and manage study timelines/budgets; Serve as primary contact for CROs and external service providers; Develop and maintain study documents (CSP, CSR, study plans); Oversee TMF completion and QC activities; Manage study budgets and financial risks; Ensure inspection readiness and compliance with ICH-GCP; Report quality issues and lead CAPAs; Provide performance feedback and mentor team members.
Seniority
Senior, hands-on IC with mentorship responsibilities