Global Clinical Study Manager
On-siteMontréal, Quebec, Canada
Job Summary
Oversee global clinical trial strategy from start-up through completion, ensuring studies comply with protocols, Good Clinical Practice, and regulatory requirements. Act as the primary Sponsor contact for CRO Project Directors and functional leads while partnering with Clinical Project Managers to translate recruitment targets into country-specific execution plans. Develop study plans, oversee site selection and feasibility, and manage project timelines, milestones, and budgets to meet deliverables. Identify study risks, develop mitigation strategies, and handle regulatory inspections and audits. Monitor participant safety, ensure data integrity through collection and reporting, and implement corrective actions as needed.
Required Qualifications
- 8+ years of demonstrated work experience in clinical study management
- Bachelor's degree in a related field
- Strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management
- Previous experience as a CRA, or experience working at clinical sites
- Strong organizational and project management skills, with the ability to prioritize and manage competing deadlines
- Bilingual with excellent communication skills, both written and verbal
- Ability to collaborate effectively with internal teams, external vendors, and clinical investigators
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software
- Certified in Clinical Research, such as ACRP, SOCRA
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