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.
Responsibilities
• 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 escalate material issues in a timely manner.
• 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
Qualifications & Experience
• Bachelor's degree or higher in nursing, life sciences, health sciences, or a related discipline; an equivalent combination of education and relevant clinical research experience may be considered.
• Typically 7+ years of pharmaceutical, biotechnology, or CRO experience, including at least 6 years of clinical research experience with increasing responsibility.
• Demonstrated experience managing Phase 1-3 clinical studies or substantial regional components from start-up through close-out and clinical study report delivery.
• Experience working in a fully or substantially outsourced operating model, including selection, contracting, oversight, and performance management of CROs and specialist vendors.
• Strong working knowledge of ICH-GCP, applicable FDA, EMA, and local regulatory requirements, sponsor oversight expectations, inspection readiness, and clinical quality management principles.
• Proven ability to manage complex timelines, budgets, risks, priorities, and cross-functional dependencies in a global matrix organization.
• Strong analytical, organizational, and problem-solving skills, with consistent attention to detail and a proactive, accountable working style.
• Excellent written and verbal communication skills in English, with the ability to influence internal and external stakeholders across cultures and levels of seniority.
• Ability to work effectively and independently in a dynamic, flexible, and innovative environment while managing multiple responsibilities under pressure.
• Willingness and ability to travel domestically and internationally based on study needs.
