Strategy Insights & Planning/R&D Clinical Manager

ZS Associates Europe   •  

Princeton, NJ

Industry: Professional, Scientific & Technical Services

  •  

5 - 7 years

Posted 52 days ago

This job is no longer available.

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 experienceworking with eClinical systems and data including CTMS, EDC, ePRO, CDMS, IVR, clinical registries and real world data (RWD).
  • Experience working withCROs 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.