Clinical Trial Lead (m/w/d)
Core
Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, acting as the accountable point for delivery, quality, and financial control.
Role type
Senior Clinical Trial Lead (Project Management)
Builds
Operational performance of clinical trials (preparation, initiation, conduct, close-out, reporting) for client project teams
Domain
Clinical Research / Pharmaceutical Trials
Deliverable
client delivery
Required skills
Global cross-functional team leadership, strategic oversight of timelines and quality, protocol and documentation authoring, GCP/ICH regulatory compliance, interdisciplinary team facilitation, risk management, financial control, staff mentoring, therapeutic area expertise (oncology, inflammatory, CMR), clinical pharmacology application
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies; Author and manage essential trial documentation including protocols and informed consent forms; Ensure consistent use of study tools and adherence to GCP/ICH guidelines; Lead interdisciplinary core trial teams and facilitate Trial Oversight Meetings; Manage and mentor clinical operations staff including performance appraisals; Monitor and guide financial aspects of trials including scope, budget, and change control; Consult with pharmacogenetics and safety experts on adverse events and side effect profiles
Seniority
Senior, hands-on IC with management responsibilities
