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.
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
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.