Global Study Manager – Project Leader

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

📋 Description

• Provide operational leadership across the entire clinical study lifecycle.

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

• Oversee study management, site management, CRO, and vendor deliverables.

• Coordinate regional and country operations alongside CRO activities.

• Establish recruitment targets, delivery milestones, study startup, monitoring, and study-level plans.

• Lead the operational sub-team and represent it within the core study team.

• Drive operational decision-making and contribute to operational strategy and protocol design.

• 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 the setup of the interactive randomization system.

• Manage vendor oversight, escalations, contracts, budgets, invoices, purchase orders, and cost variances.

• Coordinate country-level feasibility, site approvals, site activation plans, Trial Master File setup, risk planning, protocol training, and investigator meetings.

• Resolve or triage site-level issues in collaboration with cross-functional teams and CROs.

• Lead activities related to inspection readiness, site readiness, study closure, and resource release.

• Review study metrics, analytics, reports, and dashboards to identify risks and implement mitigations.

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

• Review trends in protocol deviations and forecasts for subject enrollment and discontinuation.

• Facilitate calls with study management vendors.

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

• Advocate for harmonized processes, continuous improvement, quality assurance, and excellence in study management deliverables.

• Support audits and inspections as a resource for study management.

⛳️ Requirements

• Experience in clinical research and/or study management.

• Proven study management/leadership experience.

• Experience in overseeing CROs and vendors.

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

• Fluency in both written and spoken English is required.

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

• Ability to travel as required, including for investigator meetings, vendor kick-off and reset meetings, and internal global or department-level meetings.

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

• A solid understanding of responsibilities beyond one’s own function to ensure study objectives are achieved.

• Expertise in the assigned therapeutic area and study to establish strategy, identify risks, and drive operational deliverables.

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

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

• A Master’s of Science or Master’s of Business Administration degree with at least 6 years of relevant operational clinical trial experience is required.

• A scientific or technical degree is preferred.

• Comprehensive knowledge of one’s own discipline and advanced knowledge of other disciplines.

• Capability to develop ideas and lead complex projects.

• Ability to create innovative solutions for complex challenges.

• Capacity to exercise independent judgment and act autonomously.

🏝️ Benefits

• Equal opportunity employer.

• Remote work arrangement based on the employer-selected location: United States-North Carolina-Remote.