Senior Director, Regional Clinical Study Management

This is a fully remote position, open to applicants in Canada.

📋 Description

• Provide motivating leadership, proactive management, and mentorship focused on feedback for clinical study managers.

• Oversee assigned clinical study portfolios along with specific therapeutic areas or assets.

• Execute regional studies or portfolios ensuring inspection readiness, adhering to established timelines and budget constraints.

• Serve as the regional lead for studies across various indications or programs.

• Direct regional clinical operations teams and act as the escalation point for regional challenges.

• Align regional resources and deliverables with the objectives of the portfolio.

• Create regional tools, work instructions, and standard operating procedures (SOPs).

• Guide regional clinical operations strategy and decision-making processes.

• Collaborate with regional stakeholders and provide updates on portfolio progress to senior management and Global Clinical Study Managers.

• Lead cross-departmental teams and formulate cross-functional strategies.

• Supervise clinical study planning and management from feasibility through to closeout.

• Enhance trial feasibility, country allocation, and site selection.

• Mentor and coach regional study managers and clinical research associates (CRAs).

• Provide regional insights on clinical supplies, drug inventories, labels, regulatory approvals, and comparator reimbursement.

• Drive regional data collection, data entry, and resolution of queries.

• Oversee the planning and execution of Clinical Study Reports as necessary.

• Ensure adherence to protocols, SOPs, ICH/GCP, and relevant regulations.

• Maintain readiness for inspections throughout the study lifecycle.

• Manage regional vendor requirements, investigator fees, site payments, patient travel reimbursements, resources, headcount, and budgets.

• Conduct interviews, manage, and evaluate regional clinical study managers.

• Carry out performance appraisals and support the creation of professional development plans.

⛳️ Requirements

• Bachelor's degree in a scientific or healthcare discipline, with 12+ years of progressive experience in clinical operations within the biotech, pharmaceutical, or CRO industry.

• Alternatively, a master's degree in a scientific or healthcare discipline, with 8+ years of progressive experience in clinical operations within the biotech, pharmaceutical, or CRO industry is preferred.

• Demonstrated experience in clinical research.

• Relevant experience in a leadership role within clinical functions.

• Experience with multiple studies is preferred.

• Proficient in MS Office and project planning applications.

• Willingness to travel as necessitated by business requirements.

🏝️ Benefits

• Equal opportunity employer.

• Travel may be necessary based on business needs.