Manager – TMF Operations

The Position

The Manager of TMF Operations will act as the internal TMF lead on studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends.  In addition, the Manager of TMF Operations may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP).  The primary purpose of the position is to oversee the eTMF processes and vendors, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations.

This role is onsite 5 days a week in San Diego.

Responsibilities

• Ensure staff are 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, and company processes.
• Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management
• Assist Associate Director with eTMF system administration functions (TMF Operations is the business owner of the eTMF system).
• Manage eTMF and Study TMF training for internal and external user access.
• Oversee TMF Operations role in eTMF user access process in accordance with applicable SOP/WI and escalate issues as required to Senior Management
• Direct junior TMF Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study
• Oversee clinical vendor management and escalate issues as required to Senior
• Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during
• 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
• 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 areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational
• Support the Associate Director of TMF Operations and Clinical Operation Senior Management in leading various process improvement initiatives.
• May manage direct reports.

Requirements

• 5+ years of relevant experience in clinical operations, clinical quality, or quality assurance role
• 2+ years in a managerial or lead 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).

Preferred

• 2+ years in TMF experience 
• Bachelor’s degree in a Science discipline
• Knowledge of industry compliance trends
• Proficient in Smartsheets

California pay range 125000 - 145000 USD