Global Study Manager II

This is a fully remote position, open to applicants in Brazil, +2 more states.

📋 Description

• Lead and manage the execution of global clinical trials, overseeing the entire process from sourcing strategy and study specification development to database release and inspection readiness.

• Provide quality oversight while coordinating with regional and country operations, Study Operational Managers, preferred Contract Research Organizations (CROs), and vendors.

• Establish recruitment targets and delivery milestones, ensuring adherence to agreed-upon plans.

• Act as the representative of the operational sub-team regarding study execution issues, driving 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-level monitoring, training, startup, recruitment, and protocols.

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

• Manage vendor oversight, including escalations, contracts, budgets, invoices, purchase orders, and any out-of-scope expenditures.

• Evaluate feasibility outputs, pre-trial assessment reports, study metrics, and analytics to identify and mitigate potential risks.

• Form and lead the operational sub-team, requesting additional resources as necessary.

• Ensure country feasibility, site approvals, site activation plans, and the setup of the Trial Master File.

• Coordinate study and protocol training, as well as global and local investigator meetings.

• Address or escalate site-level issues through collaboration with cross-functional teams and preferred CROs.

• Lead activities related to inspection readiness and site preparedness.

• Support decentralized capabilities at investigator sites.

• Ensure timely study closure and the appropriate release of resources following database lock.

• Interface with CROs involved in feasibility, startup, monitoring, management, and site contracting.

• Collaborate with data management to ensure alignment in data flow and timely data delivery.

• Review data reports and dashboards, escalate deviations, and oversee mitigation strategies.

• Analyze enrollment and discontinuations for financial forecasting purposes.

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

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

• Advocate for standardized processes, continuous improvement, issue resolution, inspection readiness, quality assurance, and study management deliverables.

• Work with the operational sub-team and preferred CRO to address performance-related issues.

• Assist in project-specific audits and inspections.

• Complete necessary training, timesheets, expense reports, and CV updates while adhering to Parexel processes, ICH-GCPs, and relevant requirements.

⛳️ Requirements

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

• Demonstrated leadership and study management experience.

• Experience in overseeing CROs and vendors.

• Expertise in managing per-subject costs and projections related to vendor, ancillary, and monitoring expenses.

• Proficiency in written and spoken English is mandatory.

• Willingness to work beyond core business hours as necessary to support global trials or initiatives.

• Ability to travel when required.

• In-depth knowledge of study management processes and deliverables.

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

• Bachelor of Science or Bachelor of Arts degree with at least 7 years of relevant operational clinical trial experience is required, or a Master of Science/Master of Business Administration degree with a minimum of 6 years of relevant operational clinical trial experience.

• A scientific or technical degree is preferred.

• Adherence to Parexel processes, ICH-GCPs, and other applicable regulations is essential.

🏝️ Benefits

• Opportunity to work remotely.

• Ability to travel as necessary, including for investigator meetings, vendor kickoff and reset meetings, and internal global or departmental client meetings.