Sr. Manager, GCP

1 month ago


Alameda, United States EPM Scientific Full time

Working with a mid sized pharmaceutical company dedicated to Oncology. This position will primarily focus on the oversight of GCP and PV activities. This company has 11+ clinical trials, with 6 focusing on Solid Tumor. They are looking for a GCP Senior Manager. This position will be 5 days on-site.


Responsibilities and requirements:

  • Directly support the clinical study teams and study operations
  • Implement and develop risk-based GCP audit strategies across clinical programs and/or studies.
  • Manage and/or support the development, enhancement, review, and implementation of GCP quality standards and controlled document
  • Approving and drafting Clinical SOPs.
  • CAPA management
  • CRO experience
  • 8+ years of CQA/ GCP experience


Benefits:

Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Employer-Paid Basic Life Insurance
  • Supplemental Life Insurance
  • Employer-Paid Short-Term Disability
  • Long-Term Disability
  • 401(k) Plan
  • Paid Time Off
  • Paid Holidays


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