Global Study Manager – FSP

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

📋 Description

• Lead and manage the execution of global clinical trials, from the sourcing strategy and study specifications to database release and readiness for inspection.

• Supervise study management, site management, and ensure deliverables from CROs and vendors throughout the lifecycle of the study.

• Coordinate regional and country operations along with CRO activities.

• Establish recruitment targets, delivery timelines, study startup, monitoring, and detailed study plans.

• Act as a core team member and serve as the operational representative for sub-teams.

• Propel operational decision-making and collaborate with the Clinical Study Team Lead on strategic initiatives.

• Oversee and mentor Study Operational Managers and potentially other Global Study Managers.

• Create, evaluate, and authorize startup, monitoring, recruitment, training, and other study-related plans.

• Manage drug supply and set up the interactive randomization system.

• Handle vendor oversight, manage escalations, feasibility outputs, site approvals, and activation plans.

• Ensure proper setup of the Trial Master File and contribute to risk management planning.

• Coordinate training for studies and protocols as well as global investigator meetings.

• Provide inputs for clinical trial budgets and oversee vendor budgets, contracts, invoices, purchase orders, and expenditures.

• Address or escalate site-level issues and lead activities related to inspection and site readiness.

• Support decentralized capabilities at investigator sites.

• Ensure studies are closed timely and resources are released efficiently.

• Review study metrics, analytics, data reports, and dashboards; identify risks and resolve issues.

• Interact with CRO feasibility, startup, monitoring, management, and site contracting teams.

• Collaborate with data management to ensure data flow and punctual delivery.

• Evaluate enrollment and discontinuations for financial forecasting purposes.

• Provide operational insights into protocol design and lead reviews of protocol deviation trends.

• Facilitate regular vendor calls regarding study management.

• Serve as a technical expert for study management systems and processes.

• Promote standardized processes and ensure high-quality, timely clinical trial data deliverables.

• Offer technical oversight, continuous improvement, issue resolution, inspection readiness, quality assurance, performance feedback, and review metrics.

• Identify and address performance issues within study operations staff.

• Assist in project-specific audits and inspections.

⛳️ Requirements

• Proven experience in clinical research and/or study management.

• Leadership experience in study management.

• Experience in overseeing CROs and vendors.

• Experience in managing per-subject costs, vendor and ancillary expenses, monitoring cost projections, and overall spending.

• Proficiency in written and spoken English is a must.

• Willingness to work outside of regular business hours as needed to support global trials or initiatives.

• Capability to travel as necessary, including for investigator meetings, vendor kick-off and re-set meetings, and internal global or departmental meetings.

• Extensive knowledge of study management processes and required deliverables.

• Understanding of responsibilities beyond one’s function to ensure study objectives are achieved.

• Expertise in the assigned therapeutic area and study.

• Familiarity with Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory processes.

• A Bachelor’s of Science or Bachelor’s of Arts degree with at least 7 years of relevant operational clinical trial experience is required.

• A Master’s of Science or Master’s of Business Administration degree with a minimum of 6 years of relevant operational clinical trial experience is also acceptable.

• A scientific or technical degree is preferred.

• Deep knowledge of one’s own discipline and advanced understanding of others.

• Ability to lead complex projects and devise innovative solutions to intricate problems.

🏝️ Benefits

• Option for global remote work arrangement.

• Opportunities to engage in global investigator meetings, vendor kick-off and re-set meetings, and internal global or departmental meetings.

• Professional mentorship and supervision opportunities.