Clinical Quality and Operations Lead

ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people—a fact that’s reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond. Clinical Quality and Operations Lead Location - open across the US, or Europe (Remote or office based acceptable) ZS Managers manage overall projects and client engagements. They support our clients' clinical research activities and ensure productivity and efficiency in their research operations. As a Business Consulting Manager, you will: Responsibilities: Have significant direct client interaction, managing multiple projects simultaneously; Apply advanced analysis and knowledge of clinical operation and quality to provide insights and leadership for improving Clinical Trial and QMS Quality; 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 on GCP 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 GCP and or pharma QA experience. Expertise in areas selected from study management, operations, Quality, QA, risk based and centralized monitoring strategies, protocol risk management and related retrospective and prospective analytics; Experience 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 processes, including design and optimization of SOPs. Experience managing, developing, and coaching team members Deep knowledge of Good Clinical Practices; including QMS, system and trial level Quality requirements as well as 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 ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable. Candidates must possess or be able to obtain 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. ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. 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. ZS is committed to providing and maintaining a safe workplace. Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required. Religious/Medical Exemptions can be requested on a limited basis upon hire. NO AGENCY CALLS, PLEASE.
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