Associate Clinical Operations Leader in भारत

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Associate Clinical Operations Leader based in India. Join a collaborative clinical research team dedicated to advancing medical innovation and improving patient outcomes through high-quality clinical trials. In this role, you will support the planning, coordination, and execution of clinical studies across assigned countries and project activities. Working alongside experienced clinical operations leaders, you will help ensure studies progress efficiently from start-up through close-out while maintaining rigorous quality and regulatory standards. You will coordinate cross-functional teams, monitor study performance, address site challenges, and contribute to effective patient recruitment and retention strategies. This opportunity combines clinical operations expertise, stakeholder engagement, and team coordination in a dynamic, globally connected environment. You will also have opportunities to strengthen your leadership capabilities, contribute to process improvements, and support the delivery of treatments that can make a meaningful difference in patients' lives. Accountabilities: - Clinical Team Coordination: Coordinate and guide clinical project team members on small to midsize studies, establish productivity targets, provide performance feedback, and contribute to study-specific training. - Study Start-Up and Planning: Support study initiation activities by contributing to project plans, site selection strategies, monitoring plans, and patient recruitment and retention strategies. - Study Performance Monitoring: Track project timelines, patient enrollment and retention, site performance, and data-cleaning progress to support timely, high-quality study delivery.

- Site Management and Issue Resolution: Address escalated site issues, identify operational risks early, conduct root cause analysis, and support the development and implementation of contingency plans. - Stakeholder Communication: Maintain effective communication with internal teams, sponsors, clinical investigators and research sites, external customers, and third-party vendors, responding promptly to urgent requests and emerging concerns. - Resource Management: Assess project staffing and resource requirements, monitor resource utilization throughout the study life cycle, and support efficient allocation of clinical operations resources. - Regulatory Compliance and Quality Assurance: Ensure study activities comply with International Council for Harmonisation Good Clinical Practice (ICH-GCP), applicable local regulatory requirements, standard operating procedures (SOPs), work instructions, and operational guidelines. - Audit and Inspection Readiness: Prepare for and participate in audits and inspections, maintain accurate study documentation, and support the quality review and upkeep of central study files. - Study Close-Out and Data Management: Collaborate with project leaders and data operations teams on database lock, project close-out, documentation, and archiving activities. - Cross-Functional Collaboration: Work with global project management teams and cross-functional stakeholders to coordinate deliverables, resolve operational challenges, and maintain alignment across study activities. - Continuous Improvement: Contribute to process improvement initiatives, document lessons learned during study close-out, and identify opportunities to enhance operational efficiency and study quality. - Team Development: Act as a positive role model, share clinical operations knowledge, and help foster accountability, collaboration, and continuous learning across virtual teams. Requirements: - Education: A degree in life sciences, a nursing qualification, or equivalent relevant clinical or clinical management experience.