Casey Harverstick

Casey Harverstick

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Vice President, Study Start-Up and Regulatory Affairs
Austin, Texas, United States

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Jobs verified_user 0% verified
  • ERGOMED
    Vice President, Study Start-Up and Regulatory Affairs
    ERGOMED
    Sep 2025 - Current (1 year 1 month)
  • Advanced Clinical
    Vice President, Global Study Start-Up
    Advanced Clinical
    Mar 2024 - Aug 2025 (1 year 6 months)
    The Vice President, Global Study Start Up (GSSU) is responsible for the global strategy, managing and developing staff and their performance, continuously striving for operational excellence, controlling the budget, and interacting directly with clients in a way that results in new business and repeat business.
    Vice President, GSSU ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes and develops strategies to increase efficiency, within GSSU and other functional areas and business units. He/she performs strategic, operational planning, and support for GSSU, Global Grants & Contracts (G&C), Regulatory Affairs (RA) and other functions as may be assigned at the department or business
  • Advanced Clinical
    Senior Director, Global Study Start-Up
    Advanced Clinical
    Apr 2022 - Mar 2024 (2 years)
    • Directs departmental or business unit processes, resourcing, and communications as primary escalation point for internal and external customers
    • Ensures departmental goal setting to align with company vision, mission, values and strategy.
    • Oversees the development and implementation of all departmental processes. Approves the development of company SOPs and WI related to any area concerning SSU & Regulatory or that supports new or existing departmental processes. Develops and refines processes within company which lead to greater efficiencies or competitive advantages over other companies.
    • Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional devel
  • Advanced Clinical
    Director, Global Study Start-Up
    Advanced Clinical
    Nov 2019 - Apr 2022 (2 years 6 months)
    • Directs departmental or business unit processes, resourcing, and communications as primary escalation point for internal and external customers
    • Ensures departmental goal setting to align with company vision, mission, values and strategy.
    • Oversees the development and implementation of all departmental processes. Approves the development of company SOPs and WI related to any area concerning SSU & Regulatory or that supports new or existing departmental processes. Develops and refines processes within company which lead to greater efficiencies or competitive advantages over other companies.
    • Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional devel
  • allergan
    Associate Director, Strategic Start-Up
    allergan
    Jun 2019 - Nov 2019 (6 months)
    Start Up Strategy
    o Advise and support teams in the development of the overall start up strategy, risk assessment, and contingency planning at a study, program and TA level
    o Assist teams with start-up strategy implementation and change management
    o Partner with key stakeholders to support start up milestones and KPIs, with a focus on critical path activities
    o Harmonize Start Up Tracking and provide Executive Level Start Up Metrics
    o Identify opportunities for increased efficiency and/or cost savings by achieving consistencies across studies, programs and TAs

    Team Leadership
    o Provide leadership, support, and influence to ensure timely and quality start up deliverables
    o Provid
  • Syneos Health Previously INC ResearchinVentiv Health
    Associate Director, Study Start Up, Syneos Health
    Syneos Health Previously INC ResearchinVentiv Health
    Jan 2018 - May 2019 (1 year 5 months)
    Line management responsibility for 15-20 Global Start-Up Leads.
    • SOP/OG/AD development.
    • Report to Senior Management - internal/external - regarding large global program status
    • Develop functional and regional plans and organizes priorities of their region/function.
    • Communicate with external customers regarding the status of activities on their projects as well as the overall health of the relationship.
    • Resolve basic customer relationship issues and escalate more serious issues when necessary.
    • Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the department.
    • Coordinate and conduct new employee orientation and tra
  • Inventiv Health Clinical
    Associate Director, Global Study Start Up
    Inventiv Health Clinical
    May 2014 - Dec 2017 (3 years 8 months)
    Line management responsibility for 15-20 Global Start-Up Leads.
    • SOP/OG/AD development.
    • Report to Senior Management - internal/external - regarding large global program status
    • Develop functional and regional plans and organizes priorities of their region/function.
    • Communicate with external customers regarding the status of activities on their projects as well as the overall health of the relationship.
    • Resolve basic customer relationship issues and escalate more serious issues when necessary.
    • Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the department.
    • Coordinate and conduct new employee orientation and tra
  • Inventiv Health Clinical
    Manager, Study Start-Up
    Inventiv Health Clinical
    Jan 2012 - Apr 2014 (2 years 4 months)
    Line management responsibility for 10-15 direct reports - both Global Leads and Local Specialists.
    • Develop functional and regional plans and organizes priorities of their region/function.
    • Resolve basic customer relationship issues and escalate more serious issues when necessary.
    • Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the department.
    • Participate in internal or external meetings.
    • Provide business development support
    • Identify, address, and follow up on performance and quality issues.
    • Track and report departmental and customer metrics.
    • Recruit, interview, hire, and on-board candidates.
    • Rev
  • Inventiv Health Clinical
    Senior Global Study Start Up Manager
    Inventiv Health Clinical
    Feb 2010 - Dec 2012 (2 years 11 months)
    Responsible for creating and executing submission strategies across multiple projects and 25+ countries for Oncology, CNS projects. Oversight of internal staff (20+ individuals). Direct communication with and reporting to client. Budget management. Attend face to face bids/proposals for potential business. Create and implement training programs. Manage multiple vendors.
  • Inventiv Health Clinical
    Senior Regulatory Specialist
    Inventiv Health Clinical
    Aug 2007 - Feb 2010 (2 years 7 months)
    Responsible for study site activation timelines across large-scale US based studies, including Oncology, CNS, Infectious Disease, and Urology. Provide metrics and projections to both client and senior management. Develop and implement department-wide processes.
  • PPD
    Research Coordination Manager
    PPD
    Jul 2002 - Jul 2007 (5 years 1 month)
    Line managment; interview candidates for employment. Responsible for long term metric reporting and project budget management. Negotiate project budgets and contracts with hospitals/institutions. Attend and present at bid defense meetings with large pharmaceutical companies.
Education verified_user 0% verified
  • The University of Texas at Austin
    BA, English
    The University of Texas at Austin
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