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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 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.

 

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 Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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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.

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