Global Clinical Study Manager
Core
Lead and manage clinical trials from start-up through completion, ensuring efficient execution, data integrity, and regulatory compliance for breakthrough medicines.
Role type
Senior Clinical Study Manager (Global)
Builds
Global clinical trial programs for antibody-based medicines in endocrinology, women's health, immunology, and oncology.
Domain
Biotechnology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, Good Clinical Practice (GCP), regulatory compliance, study planning and execution, risk mitigation, budget and timeline management, data integrity oversight, participant safety monitoring
Preferred skills
CRA experience, clinical site experience, bilingualism (French/English), Clinical Research certification (ACRP/SOCRA), proficiency in CTMS and EDC systems
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC)
Responsibilities
Oversee global strategy of clinical trials including planning, execution, monitoring, and close-out; Ensure studies adhere to approved protocols, GCP, and regulations; Act as primary Sponsor contact for Global CRO Project Directors; Partner with Clinical Project Managers to translate recruitment targets into country-specific plans; Develop and review study plans, protocols, and documents; Manage project timelines, milestones, and budgets; Identify risks and develop mitigation strategies; Oversee collection, analysis, and reporting of clinical trial data; Monitor and ensure safety and welfare of study participants
Seniority
Senior, hands-on IC
