Senior Director, Regional Clinical Study Management
New
J
JobgetherClinical Operations
CanadaFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 12+ years of progressive experience in clinical operations; 8+ years with a master's degree.
- Required Skills
- Microsoft OfficeBudget managementRisk Management
Requirements
- Bachelor's degree in a scientific or healthcare discipline.
- 12+ years of progressive experience in clinical operations within biotechnology, pharmaceutical, or CRO environments.
- Master's degree preferred (8+ years of experience accepted in combination with advanced degree).
- Proven clinical research experience, including team leadership responsibilities.
- Strong understanding of clinical trial planning, feasibility, site management, data collection, and inspection readiness.
- Demonstrated ability to lead regional or cross-functional clinical operations teams.
- Strong knowledge of clinical research quality standards including ICH/GCP and regulatory requirements.
- Experience with resource planning, financial and budget considerations, and vendor management.
- Excellent people-management, communication, negotiation, and decision-making skills.
- Proficiency with Microsoft Office and project-planning applications.
- Willingness to travel as required by business needs.
Responsibilities
- Provide leadership, coaching, and performance feedback to regional clinical study managers and operations professionals.
- Lead regional delivery for assigned clinical studies, ensuring milestones, quality standards, and budgets are met.
- Oversee study planning and execution from feasibility and site selection through recruitment, data collection, and closeout.
- Act as a regional escalation point for complex operational issues, identifying risks and coordinating resolutions with stakeholders.
- Establish and reinforce regional quality expectations, ensuring compliance with protocols, SOPs, and ICH/GCP standards.
- Develop and optimize regional work instructions, SOPs, tools, and processes for improved execution efficiency.
- Manage regional vendor strategies, resource forecasting, and budget decisions.
- Communicate portfolio progress, risks, and resource needs to senior management and global leadership.
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