Associate Director, Clinical Study Lead

Summary

We are seeking a (Regional) Clinical Study Lead at senior manager / associate directorslevel to provide operational leadership for the planning and execution of one or more clinical studies, with direct accountability for assigned regions, countries, and delegated study activities. You will serve as the principal clinical operations contact for the assigned scope, coordinating cross-functional teams, investigative sites, CROs, and specialist vendors to deliver studies safely, on time, within budget, and in compliance with the protocol, ICH-GCP, applicable regulations, and company procedures.

The ideal candidate combines strong end-to-end clinical study management experience with effective CRO oversight, disciplined risk management, and the ability to lead through influence in a global matrix environment.

• Provide operational leadership for the planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions, ensuring delivery against approved scope, timelines, quality standards, and budget.
• Serve as the principal Clinical Operations representative on cross-functional study teams and associated sub-teams, clearly communicating operational status, risks, assumptions, dependencies, and recommendations.
• Develop, review, and maintain integrated study execution plans, regional and country strategies, enrollment plans, oversight plans, monitoring plans, study manuals, and operational trackers.
• Contribute operational input to protocols, informed consent forms, eCRFs, investigator materials, clinical study reports, and other critical study documents.
• Lead or oversee country and site feasibility, site identification, qualification, selection, activation, training, enrollment, maintenance, and close-out activities for the assigned scope.
• Contribute to CRO and vendor selection and oversight activities, including scope definition, contracting support, performance expectations, governance, issue resolution, change control, invoice review, and reconciliation.
• Monitor study and vendor performance through meaningful KPIs, quality indicators, milestones, forecasts, and dashboards; implement corrective actions and esc
• Identify operational, quality, timeline, budget, and compliance risks; maintain mitigation plans and coordinate resolution with the Global Clinical Study Lead and cross-functional stakeholders.
• Provide accurate inputs to study timelines, budgets, accruals, resource forecasts, enrollment forecasts, clinical supply forecasts, and scenario planning activities.
• Coordinate regional or country-level investigator meetings, site communications, training, and engagement activities in partnership with relevant internal and external stakeholders.
• Ensure sponsor oversight activities are documented and inspection-ready, including appropriate management of the eTMF, essential documents, monitoring deliverables, deviations, CAPAs, and study correspondence.
• Ensure timely completion of database-lock readiness, document reconciliation, site and vendor closure, final payments, archiving, and delivery of Clinical Operations content for the clinical study report and appendices.
• Support audits, inspections, and health-authority interactions by providing complete, accurate, and traceable operational documentation and responses.
• Provide technical guidance, coaching, and mentoring to junior Clinical Operations team members and contribute to departmental standards, tools, and process improvements.
• Act as back-up for the Global Clinical Study Lead or other study leadership roles as assigned

• Bachelor's degree or higher in nursing, life sciences, health sciences, or a related discipline; an equivalent combination of education and relevant clinical…