JOB OVERVIEW
The Clinical Quality Assurance Manager will be responsible for ensuring clinical processes are conducted in accordance with all applicable guidelines and regulations. The C/QA Manager will also develop, perform and manage QA activities related to clinical trial management, presiding over clinical audits and management of our clinical data. This role reports to the Chief Medical Officer.
This position is REMOTE and can be done from anywhere in the USA or Ontario, Canada.
JOB DUTIES
1. Clinical Trial Oversight
• Establish a clinical quality assurance program working within the company’s comprehensive Quality System
• Continuously improve clinical department operations and procedures to ensure compliance with applicable regulations and study data collected support the objectives of the study
• Ensure all processes contributing to the performance of a clinical trial are conducted properly o Keep up to date with all related quality legislation and compliance issues
• Manage Clinical Quality Assurance Program
o Manage clinical trial deviations and implement CAPA when necessary
o Evaluate quality events, incidents, queries, and complaints
o Manage clinical quality improvement programs
o Manage SAE reconciliation to identify risks and implement proper solutions
• Manage and maintain clinical databases
• Assist with compilation and prepare materials for submission to regulatory agencies
o Annual reports and quality trending reports
• Manage clinical audits o Ensure investigator, vendor, facility and system audits are conducted
o Communicate any critical compliance risks noted from these activities to senior management
• Maintain department training compliance with GCPs, & various regulations and guidelines
• Participate in clinical site/investigator training
2. Trial Master File (TMF) Management
• Oversee TMF set-up, maintenance and archive
• Process study documentation in accordance with internal procedures, GCP guidelines, and study specific TMF plans
• Support document collection activities including naming conventions, email archiving, and TMF filing
• Perform quality review of documents submitted for TMF filing and liaise with internal teams to resolve any identified issues
• Develop tracking and metrics related to TMF management
• Lead TMF preparations/reconciliation prior to audits and inspections
• Ensure security and auditability of electronic TMF materials, including the document archive
3. Clinical Document Management
• Create, maintain, and track clinical documents within a department specific document control framework and ensure consistency with overall Quality System’s document management
• Assist in writing/reviewing SOPs and other quality related documents
EDUCATION & CERTIFICATIONS
Bachelor or Master degree in a relevant field, with prior experience in a GxP environment
WORK-RELATED SKILLS & EXPERIENCE
Experience working in Cell & Gene Therapy (REQUIRED)
Experience in Quality Document Management (REQUIRED)
Trial Master File (TMF) Management (REQUIRED)
Ability to multi-task and work effectively in a fast-paced, rapidly changing environment
Ability to manage complex schedules and priorities
Excellent people and relationship management skills; high level communication
Strong presentation and writing skills and the ability to present data