The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Global Study Lead (FSP) based in India.
This is a senior clinical operations leadership role responsible for the global delivery of complex clinical studies. You’ll provide end-to-end operational leadership, from study feasibility and planning through execution, closeout, and clinical study reporting. The role involves coordinating multidisciplinary global teams, external vendors, CROs, and regional stakeholders. You’ll oversee timelines, budgets, risks, quality, recruitment, data readiness, and regulatory compliance across international markets. The position requires strong experience in oncology studies and the ability to navigate complex clinical development environments. You’ll serve as a central operational leader, communicating study progress and risks to senior stakeholders while driving informed decisions. This fully remote opportunity offers the chance to influence global studies while working with diverse clinical and functional teams.
Accountabilities
- Own the day-to-day operational management of global clinical studies and act as the primary Clinical Operations representative.
- Lead cross-functional study teams spanning clinical operations, data management, biostatistics, medical monitoring, regulatory, safety, supply chain, and other relevant functions.
- Develop and maintain study timelines, operational plans, risk management plans, enrollment strategies, and other key study documentation.
- Drive study milestones and deliverables while ensuring alignment between global study strategy and regional execution.
- Oversee country start-up, site activation, recruitment, monitoring, study closeout, and consistent protocol execution across regions.
- Manage CROs and external vendors, monitoring performance, service quality, contractual commitments, timelines, and operational escalations.
- Monitor study budgets, forecasts, and spending against plan while identifying resource gaps, financial risks, and opportunities for effective resource management.
- Identify and manage operational risks, including recruitment delays, protocol deviations, data-quality concerns, supply issues, and inspection-readiness risks.
- Lead mitigation and contingency planning and ensure timely escalation and resolution of significant study issues.
- Ensure study activities comply with ICH-GCP, applicable local regulations, SOPs, protocol requirements, and relevant quality standards.
- Support audit and regulatory inspection readiness and oversee corrective and preventive actions when required.
- Serve as the central operational communication point, providing clear updates to senior leadership, study teams, regional teams, sponsors, and external partners.
- Lead governance meetings and study reviews, ensuring decisions, actions, and accountabilities are clearly established.
- Monitor enrollment, data cleaning, query resolution, database-lock readiness, and other critical study metrics.
- Review operational KPIs and use study data to identify trends, risks, and opportunities for process improvement.
- Make operational decisions that balance quality, timelines, cost, and patient safety while driving continuous improvement.
- Bachelor’s degree in life sciences or a related discipline, with a strong understanding of clinical development and regulatory processes.
- 15+ years of relevant clinical study management experience at a global level.
- Deep experience across clinical research, including study management, monitoring, and data management.
- Significant experience in oncology clinical studies.
- Proven experience managing global studies across regions including North America, EMEA, and APAC; exposure to LATAM, China, Japan, and Africa is an asset.
- Demonstrated end-to-end study management experience, from feasibility through clinical study reporting/CSR.
- Experience with Phase II and Phase III studies; Phase I and Phase IV experience is an advantage.
- Proven cross-functional leadership experience, including the ability to lead internal and external meetings and coordinate multidisciplinary teams.
- Experience contributing to clinical protocols, informed consent forms, study plans, and clinical study risk-management activities.
- Strong understanding of clinical systems, study processes, sample management, quality requirements, ICH-GCP guidelines, and SOPs.
- Strong clinical budget management and financial planning experience.
- Extensive vendor and CRO management experience.
- Exposure to competent-authority inspections, such as FDA, EMA, MHRA, or PMDA; involvement in studies supporting pivotal drug-registration submissions is an advantage.
- Strong project-management capabilities covering scope, budget, timelines, resources, risks, and associated project-management tools.
- Excellent written and verbal English communication skills, with the ability to explain and negotiate complex clinical topics with diverse technical and functional stakeholders.
- Strong stakeholder-management and interpersonal skills, with the ability to communicate effectively with clinical, regulatory, statistical, data, safety, medical, laboratory, and vendor teams as well as senior management.
- Demonstrated leadership ability, including motivating, empowering, and developing others to achieve individual, team, and organizational objectives.
- Strong analytical, organizational, and decision-making skills, with the ability to manage competing priorities in complex global programs.
- Fully remote position based in India.
- Full-time, permanent employment.
- Standard Monday-to-Friday work schedule.
- Opportunity to lead complex global clinical studies across multiple regions and functions.
- Exposure to multidisciplinary clinical development, regulatory, data, safety, medical, and operational teams.
- Opportunity to work on oncology studies and contribute to programs supporting important therapeutic development.
- Scope for significant ownership across study planning, execution, risk management, vendor oversight, quality, and delivery.
- Collaboration with global stakeholders and senior leadership in a complex clinical research environment.
- Reasonable accommodations are available during the application and employment process for qualified individuals with disabilities, subject to applicable requirements.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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