Associate Clinical Operations Leader

• Support the planning, coordination, and execution of clinical studies.
• Coordinate cross-functional teams.
• Monitor study performance.
• Address site challenges.
• Contribute to effective patient recruitment and retention strategies.
• Strengthen leadership capabilities.
• Contribute to process improvements.
• Support the delivery of treatments.

Key Responsibilities

• 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 & Tech Stack

• Education: A degree in life sciences, a nursing qualification, or equivalent relevant clinical or clinical management experience.
• Clinical Research Experience: Substantial experience in clinical research operations, including experience as a Clinical Research Associate (CRA) or in an equivalent clinical research role.
• Clinical Trial Knowledge: Strong understanding of the full clinical trial life cycle, including study start-up, site management, monitoring, data cleaning, close-out, and archiving.
• Regulatory and Compliance Expertise: Knowledge of ICH-GCP guidelines, local regulatory requirements, clinical trial procedures, and applicable quality standards.
• Clinical Coordination Experience: Experience coordinating clinical activities or teams is preferred, particularly experience gained in a Senior CRA or Senior Clinical Management Associate (CMA) position.
• Monitoring Experience: Previous on-site clinical monitoring experience is an advantage.
• Leadership and Stakeholder Management: Ability to coordinate virtual teams across different locations and cultures, influence stakeholders diplomatically, negotiate effectively, and build trusted working relationships.
• Analytical and Problem-Solving Skills: Strong root cause analysis, issue resolution, and critical-thinking abilities, with the capacity to anticipate risks and implement practical solutions.
• Communication Skills: Excellent written and spoken English, with proficiency in relevant local languages where required for assigned countries.
• Organization and Time Management: Strong planning, prioritization, and multitasking skills, combined with attention to detail, a sense of urgency, and a commitment to high-quality work.
• Technical Proficiency: Working knowledge of Microsoft Office applications (Excel, Word, PowerPoint, Outlook), and WebEx or comparable collaboration tools. Willingness to learn and become proficient in relevant clinical operations systems.
• Adaptability and Collaboration: Ability to work effectively with cross-functional teams, manage competing priorities, respond to changing study needs, and contribute positively to a fast-paced, international environment.
• Travel Flexibility: Willingness and ability to travel when required by assigned studies or project responsibilities.

Location

• India