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About the role
- Global Study Manager leading operational delivery of Parexel’s clinical trials, from study startup through database release and inspection readiness. Overseeing CROs, vendors, budgets, sites, and cross-functional study teams.
Responsibilities
- Lead and coordinate global clinical trial execution from sourcing strategy and study specification through database release and inspection readiness
- Oversee study management, site management, CRO, and vendor deliverables throughout the study lifecycle
- Coordinate regional and country operations and CRO activities
- Set recruitment targets, delivery milestones, study startup, monitoring, and study-level plans
- Serve as a core team member and operational sub-team representative
- Drive operational decision-making and partner with the Clinical Study Team Lead on strategy
- Supervise and mentor Study Operational Managers and potentially other Global Study Managers
- Develop, review, and approve startup, monitoring, recruitment, training, and other study plans
- Oversee drug supply management and interactive randomization system setup
- Manage vendor oversight, escalations, feasibility outputs, site approvals, and site activation plans
- Ensure Trial Master File setup and contribute to risk planning
- Coordinate study and protocol training and global investigator meetings
- Provide clinical trial budget inputs and monitor vendor budgets, contracts, invoices, purchase orders, and spend
- Resolve or triage site-level issues and lead inspection readiness and site readiness activities
- Support decentralized capabilities at investigator sites
- Ensure timely study closure and resource release
- Review study metrics, analytics, data reports, and dashboards; mitigate risks and resolve issues
- Interface with CRO feasibility, startup, monitoring, management, and site contracting groups
- Coordinate with data management to ensure data flow and timely delivery
- Assess enrollment and discontinuations for financial forecasting
- Provide operational input into protocol design and lead protocol deviation trend reviews
- Facilitate routine study management vendor calls
- Serve as a technical expert for study management systems and processes
- Champion harmonized processes and high-quality, timely clinical trial data deliverables
- Provide technical oversight, continuous improvement, issue escalation and resolution, inspection readiness, quality assurance, performance feedback, and metrics review
- Identify and resolve study operations staff performance issues
- Support project-specific audits and inspections
Requirements
- Experience in clinical research and/or study management
- Study management and leadership experience
- Experience overseeing CROs and vendors
- Experience managing per-subject costs, vendor and ancillary costs, monitoring cost projections, and spend
- Fluency in written and spoken English required
- Ability to work outside core business hours as required to support global trials or initiatives
- Ability to travel as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings
- Exceptional knowledge of study management processes and deliverables
- Knowledge of responsibilities beyond one's function to ensure study goals are met
- Expertise within the assigned therapeutic area and study
- Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations
- Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
- Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
- Scientific or technical degree preferred
- Exceptional knowledge of own discipline and advanced knowledge of others
- Ability to lead complex projects and develop innovative solutions to complex problems
Benefits
- Global remote work arrangement
- Opportunities to participate in global investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings
- Professional mentorship and supervision opportunities
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