Clinical Project Manager
Core
Regional Lead and tactical owner of study execution for clinical trials in assigned countries, leading cross-functional teams to deliver on trial goals while maximizing clinical trial footprint.
Role type
Senior Clinical Project Manager (Regional Lead)
Builds
Clinical trials for antibody-based medicines in endocrinology, women's health, immunology, and oncology
Domain
Biotechnology / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial management, site activation, regulatory compliance (ICH-GCP, FDA, Health Canada), protocol implementation, ethics landscape navigation, site qualification, cross-functional team leadership
Preferred skills
Advanced CTMS, eTMF, and EDC platform proficiency, data-driven decision-making, creative thinking, attention to detail
Technologies
CTMS, eTMF, EDC
Responsibilities
Lead cross-functional country- and regional-level study teams to ensure clinical supply and regulatory goals are aligned; Develop and maintain Country or Regional Execution Plan(s) to ensure local site activation meets global milestones; Manage the execution of clinical trials, serving as the primary liaison in the assigned countries; Identify and qualify high-performing private research sites to diversify the profile beyond traditional academic centers; Oversee the operational implementation of protocols, ensuring site-level execution matches scientific intent; Navigate the specific regional ethics landscape to ensure competitive start-up at local sites
Seniority
Senior, hands-on IC with mentorship responsibilities
