This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Operations (FSP) based in India.

This is a fully remote leadership opportunity overseeing clinical operations professionals supporting multiple clinical programs and FSP client engagements.
You will lead, coach, develop, and performance-manage clinical operations teams while ensuring strong delivery against quality and operational KPIs.
The role combines people leadership, resource planning, clinical oversight, quality management, and client partnership.
You will serve as a key escalation point for performance, training, compliance, and project delivery matters.
Working closely with senior leadership and client teams, you will help optimize workflows, manage risks, and drive continuous improvement.
The position offers exposure to diverse clinical programs and opportunities to influence operational strategy across a dynamic global environment.
Travel to clinical trial sites across India may be required, with up to 25% travel.

• Lead, coach, mentor, and provide work direction to clinical operations professionals, supporting performance, engagement, and career development.
• Conduct performance reviews and career discussions, support recruitment and selection, and facilitate onboarding and induction for new team members.
• Oversee resource allocation and workflow planning, partnering with project and functional leads to optimize operational delivery and address issues that may affect project timelines or outcomes.
• Ensure employee records, CVs, training documentation, position profiles, timesheets, and expense reports remain complete, accurate, and up to date.
• Deliver and support training on SOPs, Working Practice Documents, local requirements, clinical operations processes, and applicable regulatory expectations; identify and address training gaps.
• Promote adherence to ethical, regulatory, and quality standards, including ICH/GCP and applicable regulatory requirements.
• Monitor employee and project performance through clinical operations systems and dashboards, reviewing KPIs, project status, quality indicators, and operational metrics.
• Conduct or support Performance Assessment Visits and other quality assessments to evaluate monitoring capabilities and project execution.
• Partner with quality teams on audits, quality issues, CAPA activities, and corrective actions, supporting both internal and client-facing quality assurance processes.
• Work closely with client and sponsor teams to achieve program KPIs, manage risks, resolve issues, and maintain strong operational relationships.
• Support risk-based monitoring approaches and identify opportunities to improve clinical operations processes, efficiency, and scalability.
• Contribute to bids, business development activities, strategic planning, and initiatives designed to strengthen departmental performance and operational capabilities.

Requirements:

• Bachelor’s degree in Life Sciences or a related discipline is preferred.
• 12+ years of experience in clinical monitoring, trial management, eTMF management, onsite monitoring, or related clinical operations activities.
• 4+ years of experience managing clinical operations professionals such as CRAs, Clinical Trial Coordinators, or Project Support Coordinators.
• Demonstrated experience managing one or more FSP clients as a primary or single point of contact.
• Experience with workflow allocation, resource management, performance management, quality/CAPA activities, reporting, and operational metrics.
• Strong knowledge of clinical trial monitoring practices, including both remote and onsite monitoring.
• Understanding of clinical research regulations, SOPs, working practice documents, ICH/GCP principles, and FDA guidelines, with the ability to apply them effectively.
• Strong understanding of medical research data, medical terminology, and relevant therapeutic areas.
• Advanced leadership, mentoring, supervisory, organizational, negotiation, and conflict-resolution skills.
• Excellent written and verbal English communication skills, with the ability to collaborate effectively with clients, sponsors, senior leaders, and distributed teams.
• Strong analytical and problem-solving abilities, with the flexibility to manage changing priorities and complex operational challenges.
• High attention to detail, strong teamwork skills, and a demonstrated ability to build productive relationships.
• Comfortable using clinical operations and reporting systems for data entry, analysis, archival, retrieval, and performance monitoring.
• Willingness and ability to travel to clinical trial sites across India, up to approximately 25%.

Benefits:

• Fully remote position based in India.
• Opportunity to lead and develop clinical operations teams within a global clinical research environment.
• Exposure to diverse clinical programs, FSP client engagements, and international stakeholders.
• Opportunities to contribute to strategic planning, process improvement, quality initiatives, and operational transformation.
• Professional development through leadership, clinical operations, and regulatory exposure.
• Collaborative environment focused on scientific excellence, innovation, and meaningful contributions to healthcare and clinical research.
• Supportive culture emphasizing employee development, teamwork, and career growth.
• Reasonable accommodations available throughout the application and employment process for individuals with disabilities.

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!

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