Senior Clinical Study Inspection Readiness Manager

1 month ago


Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

The Senior Clinical Study Inspection Readiness Manager is responsible for leading clinical inspection readiness activities to support the Program Operations Leader and Clinical Study Lead(s) for one or more assigned clinical programs within Clinical Trial Management. This role requires strong leadership, project management skills, and a deep understanding of ICH/GCP and current regulatory guidelines.

Key Responsibilities
  • Lead clinical inspection readiness activities to support the Program Operations Leader and Clinical Study Lead(s)
  • Develop and implement inspection readiness plans to ensure compliance with ICH/GCP and regulatory guidelines
  • Collaborate with cross-functional teams to ensure effective communication and coordination
  • Provide guidance on compliance and regulations to ensure CTM staff and study teams are following targeted SOPs
  • Track and ensure positive Financial Disclosures are reviewed by Regeneron's Compliance Committee
  • Support the collection and review of CTM led staging room documents and pre-requested documents in preparation for mock/actual inspections
  • Attend mock and actual inspections and act as a project manager during the inspection process
  • Ensure that significant CTM related findings that impact process changes/improvements are discussed with TA and Program Operations Leaders across the portfolio
Requirements
  • Minimum of a Bachelor's degree and 8+ years relevant industry related experience
  • Extensive knowledge in research & development with experience in global clinical trial operations
  • Strong knowledge of ICH/GCP and current regulatory guidelines/directives
  • Quality focused with effective project management skills, cross-functional team leadership and organizational skill
About Regeneron

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.



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