Skip to content

Job Openings

Sr. Study Director

Northwood, OH 43619

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

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.

 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial