Global Study Manager II

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

📋 Description

• Lead and coordinate the execution of global clinical trials, managing everything from sourcing strategy and study specifications to study startup, database release, and readiness for inspections.

• Provide oversight for quality and coordinate with regional and country operations, Study Operational Managers, preferred CROs, and vendors.

• Establish recruitment targets and delivery milestones, ensuring adherence to approved plans.

• Act as the operational sub-team representative on matters concerning study execution and facilitate operational decision-making alongside the Clinical Study Team Lead.

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

• Develop, review, and approve plans for study startup, monitoring, recruitment, training, and other study-level activities.

• Oversee management of drug supply and the setup of the interactive randomization system.

• Manage vendor oversight, including escalations, contracts, budgets, invoices, purchase orders, and spend forecasts.

• Assess feasibility and pre-trial evaluation results, approve sites, and evaluate site activation strategies.

• Ensure the setup of the Trial Master File and the closure of applicable systems.

• Lead the formation of the operational sub-team, addressing resource requests, risk planning, protocol training, and global investigator meetings.

• Resolve or triage issues at the site level by collaborating with cross-functional teams and the preferred CRO.

• Oversee activities related to inspection readiness and site preparedness.

• Analyze study metrics, analytics, data reports, and dashboards; mitigate risks and address issues.

• Manage study startup and monitoring interactions with CROs concerning feasibility, startup, monitoring, management, and contracting.

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

• Serve as a technical expert on study management systems and processes, advocating for harmonized processes and continuous improvement.

• Support audits, inspections, quality assurance activities, issue escalation, and performance feedback.

⛳️ Requirements

• Experience in clinical research and/or study management.

• Leadership experience in study management.

• Experience in overseeing CROs and vendors.

• Experience managing costs per subject, vendor and ancillary costs, monitoring cost projections, and expenditures.

• Proficiency in written and spoken English is essential.

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

• Ability to travel as needed for investigator meetings, vendor meetings, and global or departmental gatherings.

• Exceptional understanding of study management processes and deliverables.

• Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations.

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

• Alternatively, 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 required.

• A scientific or technical degree is preferred.

• Familiarity with clinical trial methodology.

• Ability to develop innovative solutions and lead complex projects.

• Capacity to exercise independent judgment and act autonomously on self-initiated projects.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and continuous learning.

• Flexible working hours and the possibility of remote work.

• Competitive salary and performance-based incentives.