Clinical Program Quality Excellence Lead - FSP Team
Core
Lead cross-functional teams in GCP inspection readiness and execution throughout the clinical study lifecycle, ensuring high-quality deliverables and TMF performance.
Role type
Senior Clinical Program Quality Excellence Lead
Builds
Inspection-ready clinical studies and compliant Trial Master Files (TMF)
Domain
Pharmaceutical clinical development and regulatory compliance
Required skills
GCP compliance, regulatory inspection readiness, Trial Master File (TMF) management, risk-based oversight, project management, CRO oversight, study execution processes, electronic document management systems (eTMF/CTMS), stakeholder influence, problem solving
Preferred skills
Veeva systems expertise, sponsor oversight experience, drug development knowledge
Technologies
eTMF, CTMS, SSU, Veeva, Microsoft Office
Responsibilities
Facilitate GCP inspection readiness and execution activities; manage inspection readiness plans and tools; oversee TMF performance and risk-based strategies; action compliance monitoring signals; lead functional teams during inspections; facilitate CAPA activities; implement process improvements.
Seniority
Senior, hands-on IC
