Oxford Global Resources is searching the most talented candidate to join one of the most creative, high-tech company, which is offering the best in class non-invasive and high definition electrical brain stimulation technology for personalized neuromodulation.
Definitely, this is a unique and potential blockbuster project in its area, so any potential and interested candidate will be evaluated not only according the present skills and knowledge but also considering the potential development within this key organization with an amazing roadmap.
Job Description
The Clinical Quality Assurance Manager will be responsible for ensuring clinical processes are conducted in accordance with all applicable guidelines and regulations. The Clinical/QA Manager will also develop, perform and manage QA activities related to clinical investigations management, and preside over clinical audits. The Clinical/QA will create and maintain SOPs and other documents necessary to conduct clinical investigations in accordance with Good clinical Practices for Medical Devices
Responsibilities
- 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
- Manage clinical trial deviations and implement CAPA when necessary
- Evaluate quality events, incidents, queries, and complaints
- Manage clinical quality improvement program
- Manage and maintain clinical databases
- Assist with compilation and prepare materials for submission to regulatory agencies
- Manage clinical audits to ensure investigator, vendor, facility and system audits are conducted
- Maintain department training compliance with GCPs, & various regulations and guidelines
- Participate in clinical site/investigator training
- 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
- 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
- Develop and maintain SOPs and other quality related documents
Requirements
- Bachelor or Master Degree in a relevant field, with specific training in GCPs
- Previous experience minimum 5 years in QA Clinical Trials in Medical Devices required with experience in FDA.
- Familiar with both MDR and FDA requirements for conducting clinical investigations
- Experience in Quality Document Management
- Experience in Trial Master File (TMF) Management
- Ability to multi-task and work effectively in a fast-paced, rapidly changing environment
- Ability to manage complex schedules and priorities
Benefits
- Professional development and career in an international and pioneering organization
