Senior Manager, TMF Operations (eTMF / Veeva Vault)

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. The company is looking for a Senior Manager to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across 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 2 years in a managerial or lead role/
• Minimum 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