Senior Manager, Clinical Standards & Processes

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. The Senior Manager of Clinical Standards & Processes will oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and provide guidance and best practices to Clinical Operations.

Requirements

• Minimum of 8 years of relevant experience in clinical operations/clinical quality or quality assurance role/minimum of 2 years in a managerial or lead role/minimum of 3 years in TMF experience (preferred)
• Minimum 2 years Veeva eTMF experience in a management role
• Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
• Experience in inspection
• Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (eTMFs)

Benefits

• Competitive salaries
• Excellent benefit package
• Paid time off
• 401k Matching
• Retirement Plan