Job details

Clinical Quality and Operations Lead - job 2 of 4

Princeton, New Jersey
United States
Insights & Analytics
Strategy Insights & Planning
17690

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.

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. Learn more

ZS’ R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. Through our “Lifecycle Evidence Strategy”, “Clinical Trial Optimization”, “Medical Affairs” and “Real World Evidence” services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area supporting our Technology and Platform services across multiple clients.

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.

Responsibilities:

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.

Qualifications:

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

Additional Skills:

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.

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 in global healthcare and beyond. 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.

ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

To Complete Your Application:

Candidates must possess or be able to obtain work authorization for their intended country of employment.

ZS is committed to providing and maintaining a safe workplace. In order to keep its employees safe, ZS recommends that all its employees and contractors be fully vaccinated against COVID-19. Proof of vaccination can be voluntarily provided upon acceptance of offer of employment.

NO AGENCY CALLS, PLEASE.

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