Clinical Quality and Operations Lead

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.
R&D Clinical Quality and Operations Lead
The Clinical Quality and Operations Lead will manage overall projects and client engagements. They support our clients' clinical research activities and ensure productivity and efficiency in their research operations.
What You'll Do

• 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.

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

• 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:

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

Willingness to travel to other global offices as needed to work with client or other internal project teams
Perks & Benefits:
ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member.
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Considering applying?
At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above.
To Complete Your Application:
Candidates must possess work authorization for their intended country of employment.
An on-line application, including a full set of transcripts (official or unofficial), is required
to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com
Salary: $190,000.00 - $212,500.00