Strategy Insights & Planning Consultant - Clinical Operations

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. 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.

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 Consultants deliver high‑quality solutions for our clients. Consultants leverage their analytic, synthesis, and communication skills to derive insights and solve business problems. Consultants apply problem‑solving frameworks to client issues, support clients in change initiatives, and employ standard analytic techniques to help guide client decisions.

• Contribute clinical operations expertise to internal knowledge development and capability building in areas such as Good Clinical Practice (GCP), ICH guidelines, and trial risk monitoring
• Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state in one or more of the following R&D domains:
  Clinical, Quality, Regulatory, and/or Safety;
• Lead project delivery execution by ensuring progress, organizing project data and coordinating team meetings focused on:
• Clinical data quality and management
• Site performance and trial efficiency
• Operational risk mitigation and process optimization
• Global clinical operations
• Biometrics
• Design and execute qualitative and/or quantitative analyses to test and analyze hypotheses (e.g., stakeholder interviews, operational data reviews, workshops, risk analysis) to generate actionable insights;
• Synthesize findings, develop recommendations and communicate results to clients and internal teams;
• Support internal capabilities and client business development;
• Coach the cross‑functional, regional and global project teams 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

• MBA with bachelor’s (and often graduate) degrees with a strong academic record in Life Sciences, Public health or related field. Alternatively, candidates may possess a PhD in a related field with a business application. In lieu of an MBA or PhD, 5‑8 years of relevant work experience may substitute;
• Preferred:
  At least 5 years of experience in clinical operations consulting or operational roles within pharma/biotech.
• Preferred:
  Clinical trial management
• Preferred:
  Data management and analytics
• Preferred:
  Drug development process consulting
• Preferred:
  Biostatistics or precision medicine
• Preferred: eCTD content authoring
• Preferred:
  Human bio‑sample management
• Preferred:
  Global clinical operations
• Preferred:
  Experience with end‑to‑end SaaS implementation, Product Management, and/or GxP Product Validation and Testing for one or more of the CTMS, EDC, eTMF, EHR/eSource, QMS, RIM, SIS
• Strong knowledge of clinical processes across functions such as regulatory, safety, quality, GCO and biostatistics.
• Motivation, good work ethic, maturity and personal initiative;
• Aptitude for, and enjoyment of, leading and managing teams;
• Effective…