TMF Operations Lead - eTMF & Compliance

Arrowhead Pharmaceuticals, Inc.; San Diego (CA); On-site; USD 125,000 - 145,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Manager of TMF Operations to lead and oversee eTMF processes, ensuring SOP/WI alignment and GDP compliance across studies. The role focuses on optimizing TMF workflows and coordinating with outsourced vendors and CROs.

The onsite position in San Diego requires 5 days a week in the office, with responsibilities spanning staff training, metrics tracking, and collaboration with Quality Assurance to prepare for health authority inspections and audits.

Qualifications

• 5+ years in clinical operations, clinical quality, or quality assurance.
• 2+ years in a managerial or lead role.
• Fundamental knowledge of US, EU and international regulatory standards (ICH GCP, FDA, EMA).
• Experience in inspection.
• Strong knowledge of vendor management and eTMF systems.

Responsibilities

• Oversee eTMF processes and ensure compliance with SOPs/WIs and GDP.
• Provide leadership on study-related eTMF issues and vendor interactions.
• Ensure metrics and tracking systems for proactive quality management.
• Manage eTMF system administration and user access.
• Collaborate with QA on inspections, audits, and CAPAs.
• Support process improvements across Clinical Operations.

Skills

TMF management

Clinical operations

Vendor management

Regulatory knowledge

GCP knowledge

Team leadership

Education

Bachelor’s degree in a Science discipline

Tools

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a Manager of TMF Operations to lead and oversee eTMF processes, ensuring SOP/WI alignment and GDP compliance across studies. The role focuses on optimizing TMF workflows and coordinating with outsourced vendors and CROs.

The onsite position in San Diego requires 5 days a week in the office, with responsibilities spanning staff training, metrics tracking, and collaboration with Quality Assurance to prepare for health authority inspections and audits.