IT Audit Manager overseeing control testing, risk assessments, and end - to - end audits at TD, a major North American bank. Presenting findings and advising management on control improvements.
About the role
- Global Study Manager leading end-to-end clinical trial operations for Parexel, a global clinical research organization. Overseeing CROs, vendors, budgets, study teams, site delivery, compliance, and inspection readiness.
Responsibilities
- Lead and coordinate global clinical trial execution from sourcing strategy and study specification through database release and inspection readiness
- Provide operational oversight of regional and country operations, CROs, vendors, study management functions, and delegated Study Operational Managers
- Set recruitment targets and delivery milestones and ensure delivery against approved study plans
- Represent the operational sub-team on study execution matters and drive operational decision-making with the Clinical Study Team Lead
- Develop, review, and approve study start-up, monitoring, recruitment, training, and other study-level plans
- Oversee drug supply management, interactive randomization systems, vendor oversight, system setup, and study completion activities
- Lead feasibility, site approval, site activation planning, Trial Master File setup, risk planning, investigator meetings, and protocol training
- Provide input to clinical trial budgets and monitor vendor costs, contracts, invoices, purchase orders, forecasts, and spend
- Resolve or triage site-level issues, lead inspection readiness and site readiness activities, and support decentralized capabilities at investigator sites
- Review study metrics, analytics, data reports, and dashboards to identify risks and drive mitigation actions
- Interface with CRO feasibility, study start-up, monitoring, management, and site contracting groups
- Coordinate with data management and cross-functional colleagues to ensure data flow alignment and timely delivery
- Assess enrollment and discontinuations for financial forecasting and provide operational input into protocol design
- Lead protocol deviation trend reviews and facilitate routine study management vendor calls
- Serve as a technical expert for study management systems and processes and champion harmonized, high-quality deliverables
- Provide technical oversight, continuous improvement, issue escalation and resolution, inspection readiness, quality assurance, and performance feedback for the operational sub-team
- Support project-specific audits and inspections and address study operations staff performance issues
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 the candidate's own function to ensure study goals are met
- Expertise within the assigned therapeutic area and study to set strategy, identify risks, and drive operational deliverables
- 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
- A scientific or technical degree is preferred
- Exceptional knowledge of own discipline and advanced knowledge of others
- Ability to develop ideas, lead complex projects, develop innovative solutions, exercise judgment, and act independently
Benefits
- Ability to work remotely
- Ability to travel, as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department level meetings
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