Clinical Quality and Operations Lead

ZS is a place where passion changes lives. As a management consulting and technology firm focused on transforming global healthcare and beyond, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping solutions from start to finish. At ZS, we believe that making an impact demands a different approach; and that's why here your ideas elevate actions, and here you'll have the freedom to define your own path and pursue cutting-edge work. We partner collaboratively with our clients to develop products that create value and deliver company results across critical areas of their business including portfolio strategy, customer insights, research and development, operational and technology transformation, marketing strategy and many more. If you dare to think differently, join us, and find a path where your passion can change lives.

• Have a significant direct client interaction, managing multiple projects simultaneously;
• Apply advanced analysis and knowledge of clinical operation and quality to provide insights for Clinical Trial Optimization;
• Leverage knowledge of Life Sciences R&D organizations, data and systems, business processes and stakeholder types to aid analyses and recommendations for strategic solution offerings;
• Represent R&D business and drive innovation, business case development, user needs assessment workshops and assist in technical solution vision and implementation plan development;
• Establish or maintain ongoing client relationships with key business decision makers that drive new business development;
• Update senior leaders, prepare and present client presentations
• Manage and advise the clinical needs assessment and requirements gathering process by meeting with stakeholders to define the business and functional requirements following user centric design best practices;
• Advise on clinical business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state;
• Coach the cross-functional project team on the business perspective and data domain to inform key project decisions;
• Coach and mentor teams, conduct & develop training programs to contribute to capability building and knowledge sharing.

• Minimum of 10 years of clinical research and development experience.
• Expertise in areas selected from study management, operations, Quality, risk based and centralized monitoring strategies, protocol risk management and related retrospective, predictive and prospective analytics;

• Knowledge of clinical development systems such as CTMS, EDC, ePRO, CDMS, IVR, clinical registries and real world data (RWD).
• Experience working with CROs and/or working within a CRO or clinical study vendor organization

• Experience in clinical trial operations, with responsibilities including the monitoring and tracking of clinical trial progress (Study startup, conduct and closeout) through analytics and Reporting
• Experience managing, developing and coaching team members
• Deep knowledge of Good Clinical Practices; ICH and regional health authority regulations.
• Experience working within a Quality Management System
• Extensive experience in metric use and development for clinical development operations and quality

• Understanding of Pharmacovigilance and Drug Safety, clinical submissions and regulatory areas of drug development

• Experience in patient centricity in drug development (patient care eco-system, recruitment process, consent process, patient communication etc.)

• Up to speed with latest industry trends in interventional trials, data collection processes, and data management with Clinical and R&D specifically.
• Proven relationship-building and maintaining skills with clients and across functional areas.
• Superior verbal and written communication, organization, analytic, planning and leadership skills.
• Ability to distill complex concepts into easy-to-understand frameworks and presentations.