Sr/Project Lead - FSP - Phase IV
Core
Client-embedded Project Lead accountable for overall delivery (quality, time, cost) of Phase IV clinical studies, managing cross-functional teams and stakeholder expectations.
Role type
Senior Project Lead (Clinical Operations)
Builds
Phase IV clinical study deliverables
Domain
Clinical Research / Biopharmaceuticals
Required skills
Phase IV clinical trial management, cross-functional team leadership, financial stewardship, risk identification and issue resolution, contract and budget management, regulatory compliance (ICH-GCP), strategic thinking
Preferred skills
Biotech experience, rare disease/auto-immune/oncology trial background
Technologies
MS Project, CTMS, TMF, IWRS, eCOA, eCRF databases, AI technology
Responsibilities
Serve as primary contact between sponsor and organization, ensure adherence to escalation pathways, manage Out of Scope activity and Con Mod negotiations, drive Risk Identification and Issue Resolution (RBQM/RESOLVE), ensure team compliance with policies and regulatory requirements
Seniority
Senior, hands-on IC