Global Study Lead
Core
Lead and coordinate cross-functional study teams to ensure clinical study progress, milestones, and quality standards in pharmaceutical R&D.
Role type
Senior clinical study lead (pharmaceutical R&D)
Builds
Clinical studies (non-drug project work also included)
Domain
Pharmaceutical industry + Clinical research
Required skills
Clinical study management, Project management, Team leadership, Regulatory knowledge, Budget management, Risk management, Quality assurance, Stakeholder management, Strategic thinking, Problem-solving
Preferred skills
Mentorship, Process improvement
Technologies
CTMS, eTMF, IXRS, ePRO, Data flow metrics dashboard
Responsibilities
Lead cross-functional study teams and coordinate study progress; Facilitate communication across functions and support team members; Act as primary point of contact for CROs and external service providers; Develop essential study documents (CSP to CSR); Oversee study performance against KPIs and timelines; Manage study budget and provide financial risk reports; Ensure inspection readiness and compliance with ICH-GCP; Oversee Trial Master File (TMF) completion; Provide performance feedback and mentor team members; Lead process improvement projects.
Seniority
Senior, hands-on IC with mentorship responsibilities