Clinical Program Quality Excellence Lead - FSP Team
Core
Lead cross-functional teams in GCP inspection readiness, TMF quality strategies, and compliance monitoring for global clinical studies.
Role type
Senior Clinical Program Quality Excellence Lead
Builds
Inspection-ready clinical studies and compliant Trial Master Files (TMF)
Domain
Pharmaceutical clinical research / Clinical Quality Assurance
Required skills
GCP compliance, TMF management, risk assessment, project management, regulatory standards, CRO oversight, stakeholder engagement, data analysis, process improvement, change management
Preferred skills
Veeva systems, drug development lifecycle, sponsor oversight
Technologies
CTMS, SSU, eTMF, Veeva, Microsoft Office
Responsibilities
Manage inspection readiness planning and execution; oversee TMF performance and risk-based strategies; facilitate CAPA activities; coordinate with CROs and SMEs; lead strategy and core team meetings; monitor study health metrics; ensure compliance with global/local regulations.
Seniority
Senior, hands-on IC
