STRATEGY INSIGHTS & PLANNING/R&D CLINICAL MANAGER (Princeton, NJ)
Z's Associates, Inc

Job Info

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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.

ZS Associates' Business Consulting 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.

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 MANAGER

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 a significant direct client interaction, managing multiple projects simultaneously;
• Apply advanced analytics and data management knowledge on clinical data sources (both internal CDMS & CTMS and real world data) 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 6 years of clinical research and development experience, preferably with 4 years of Management Consulting experience in Pharma R&D
• Expertise in the areas of study management, operations, risk based and centralized monitoring strategies 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.)

• Extensive experience working with eClinical systems and data including 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

• Proven track record of successful and continued business development including demonstrated experience driving revenue with existing clients, proposal writing and conducting product demos.

• Working knowledge of data standards like CDISC (ODM, SDTM, ADaM), OMOP and metadata management models like ISO11179 etc. and international regulations including 21CFR Part 11 and HIPAA
• MBA from top tier University with either a PhD in Life Sciences or Pharm. D preferred

Additional Skills:

• Understanding of Pharmacovigilance and Drug Safety, clinical submissions and regulatory areas of drug development
• Up to speed with latest industry trend in pragmatic interventional trials, hybrid data collection process, 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 work authorization for their intended country of employment. An on-line application, including a cover letter expressing interest and 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. We are an Equal Opportunity Employer.NO AGENCY CALLS, PLEASE.

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ZS has been recognized globally for its expertise in consulting and its flexible work environment. View ZS's accolades.

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