NAMSA
Published
02/10/2021
Location
6750 Wales Road, Northwood, OH 43619, Northwood
Category
Job Type
Contact Name
Peggy A. McGaharan
Street Address
6750 Wales Road

Description

Senior Study Director

  • Requires a minimum of a Bachelor’s degree, preferably in a scientific discipline, with 4 - 6
    years related GLP laboratory experience or 10 years relevant experience without a degree.
  • Three years previous study directing experience preferred.
    Master’s degree/PhD with a minimum of 3 year of related GLP laboratory experience. Three
    years previous study directing experience preferred
  • Advanced degree required for EMEA and APAC locations.
    Project management experience and regulatory interface preferred
    AALAS certification recommended.
    Fluency in English and local language, if different, required.
  • Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other
    individuals or departments.
  • Participates in client discussions regarding study design when needed.
  • Develops and leads moderately complex study designs as needed, serves as the primary
    contact for the client as assigned, and keeps the client informed of schedule and any
    unforeseen events or issues.
  • Establishes and ensures schedule, budget and quality commitments are met for the client.
  • Manages (motivates, communicates) internal multidisciplinary team members to ensure that
    client expectations are met.
  • Understands investigational product(s) including high-level understanding of the Medical
    Device Development Process.
  • Evaluates, analyzes, and interprets study data and presents in a clear, well-organized,
    scientifically sound report.
  • Assists with departmental training as needed.
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