Manager, TMF Operations

Arrowhead Pharmaceuticals•San Diego, CA

9d•$125,000 - $145,000•Onsite

About The Position

The Manager of TMF Operations serves as the internal TMF lead on studies, overseeing outsourced TMF work and monitoring TMF metrics and trends. The role may also lead projects to establish appropriate frameworks for TMF-related processes and maintain compliance with Standard Operating Procedures and Work Instructions (SOP/WI), Good Clinical Practice (GCP), and Good Documentation Practice (GDP). Its primary purpose is to oversee eTMF processes and vendors, ensure GCP compliance and consistency across programs, and provide guidance and best practices to Clinical Operations. The role is onsite five days a week in San Diego and may manage direct reports.

Requirements

At least 5 years of relevant experience in clinical operations, clinical quality, or a quality assurance role.
At least 2 years in a managerial or lead role.
Fundamental knowledge of U.S., EU, and international regulatory standards and guidelines for clinical trials, including ICH GCP, FDA, EMA, and ANZ regulations.
Experience in inspection.
Strong knowledge or experience in vendor management, clinical operations, and management of electronic Trial Master Files (eTMFs).

Nice To Haves

At least 2 years of TMF experience.
Bachelor’s degree in a science discipline.
Knowledge of industry compliance trends.
Proficiency in Smartsheets.

Responsibilities

Ensure Clinical Operations staff receive GCP and SOP/WI training and applicable refresher training.
Provide leadership, guidance, and oversight on study-related eTMF issues and company processes.
Ensure collection of metrics and maintenance of tracking systems to support proactive, risk-based quality management.
Assist the Associate Director with eTMF system administration; TMF Operations is the business owner of the eTMF system.
Manage eTMF and Study TMF training for internal and external users.
Oversee the TMF Operations role in the eTMF user-access process in accordance with applicable SOP/WI, escalating issues as required to Senior Management.
Direct junior TMF Operations staff in eTMF setup, maintenance, ongoing quality-control review, and final study reconciliation.
Oversee clinical vendor management and escalate issues as required to Senior Management.
Collaborate with Quality Assurance on health authority inspection preparation and provide leadership and oversight during inspections.
Collaborate with Quality Assurance on preparing for, conducting, and responding to internal and external audits and inspections, as applicable.
Facilitate ongoing quality improvement by communicating audit results, CAPAs, and GCP guidance, and providing consultation to COM and Senior Management.
Contribute to developing Clinical Operations documents, including forms, templates, SOPs, and WIs.
Ensure consistency and standardization of processes across Clinical Operations.
Collaborate with Safety, Regulatory, Legal, Finance, Project Management, and QA to support operational work.
Support the Associate Director of TMF Operations and Clinical Operations Senior Management in leading process-improvement initiatives.
May manage direct reports.