SIP Manager

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers, and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing impact to ZS.

Our most valuable asset is our people.

At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about.

ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.

Strategy Insights & Planning Manager / R&D Clinical Quality, Patient & Site Engagement Lead

The SIP Manager / Clinical Quality and Patient / Site Engagement Lead will manage overall projects and client engagements in those respective domains. They will support our clients' clinical research activities and ensure productivity and efficiency in their drug development operations.

What you'll do:

• Have 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.

What you'll bring:

• 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;
• Expertise in patient-centricity in drug development (patient care ecosystem, recruitment process, consent process, patient communication, etc.) and site relationships; ideally experience running trial recruitment programs;
• 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.

Additional Skills:

• Up to speed with the 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.

Willingness to travel to other global offices as needed to work with clients or other internal project teams.