Compensation Overview

The Position

The Associate Director of Clinical Standards & Processes will be tasked with new team member onboarding, tracking and ongoing Standard Operating Procedure/ Work Instruction (SOP/WI) review and updates as well as aligning with Quality Assurance (QA) to ensure Good Clinical Practice (GCP). The primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations.

Responsibilities

• Facilitate New Hire Orientation in collaboration with HR for Pasadena & San Diego Staff
• Onboard all new Clinical Operations staff members to Clinical Operations specific functions
• Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable
• Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, unblinded tasks, and company processes
• Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management approach
• eTMF system administrator and trainer for all internal and external users
• Direct Clinical Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study documents
• Oversee clinical vendor management and escalate issues as required to Senior Management
• Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during inspections
• Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as required
• Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls)
• Ensure consistency and standardization of processes across Clinical Operations
• Collaborate with other cross functional area (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational excellence
• Manage direct reports

Requirements:

• Minimum of 10 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 5 years in a managerial or lead role/ minimum of 2 years in clinical monitoring experience
• 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 management
• Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (eTMFs)

Preferred: 

• Master’s degree in a Science discipline
• Knowledge of industry compliance trends