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Sr. Study Director

Northwood, OH 43619

Posted: 08/17/2022 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 341445 Country: United States Is job remote?: No

Job Description


Job Description:

Duties and Responsibilities
  • Develops and leads moderately complex study design and protocols.
  • Participates in client discussions regarding study design and product development goals including regulatory submission pathway.
  • Prepares publications and/or presentations and participates in conferences, webinars, or other industry venues.
  • Provides mentoring and training to other Study Directors.
  • Participates in study specific procedures as required.
  • Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
  • Manages cross-functional projects effectively.
  • Assist Study Director(s) with protocol and report development.
  • Other duties as assigned.

Qualifications and Skills
  • Requires a minimum of a Bachelor’ s degree, preferably in a scientific discipline, with 4 - 6 years related GLP laboratory experience.
  • 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.

Technical Competencies
  • Knowledge of Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR Part 58), highly desirable
  • Knowledge and experience with quality systems
  • Familiarity with medical device development process from pre-clinical to commercialization
  • Awareness of applicable guidelines and regulations including, but not limited to USDA, USP, FDA, ISO, MHLW
  • Demonstrated knowledge of a laboratory, analysis of scientific data, technical writing, organizational and communication skills.

 
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