At ClinCapture, our mission is to build "software that saves lives." Our technology lowers the cost of clinical research by accelerating clinical study workflows, while providing a platform that protects patient privacy. ClinCapture advances the evaluation and development of new medicines, medical devices, and diagnostics which demonstrate promise for a wide range of medical conditions.
Work hours: Part-time
Compensation: $50 per hour
Job Responsibilities Include:
The Clinical Quality Systems (CQS) Manager will support the implementation and management of the Quality Systems activities across multiple teams, customers, and studies. The CQS Manager will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
The CQS Manager position is responsible for activities related to Quality Management System (QMS) oversight, audit and inspection follow up (CAPA), and for assuring the compliance of studies with Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, HIPAA, GDPR, and National regulations).
• Represents QS and provides QS guidance for project/study teams, providing GCP compliance input to deliver quality products and services
• Ensures appropriate and timely resolution of quality issues (CAPA), including potential misconduct or issues of significant deviation with projects/products
• Conducts QA audits (Vendor, Internal process, For-cause, and directed/complex audits), generates audit reports, communicates results to management and external relevant stakeholders
• Interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable
• Manages development, enhancement, and review of standard operating procedures (SOPs) and other controlled documents
• Provides GCP, HIPAA, Regulatory, and Data Protection training,
• Clinical Study Management, monitoring, or audit experience is an asset
• Experience with health authority inspections and inspection readiness activities preferred.
• Strong personal leadership with demonstrated competency interfacing with senior leaders is required
• Ability to respond to and prioritize urgent situations
• Excellent relationship management and interpersonal skills
• Strong attention to detail and commitment to good service
• BS/BA degree with 5 years of pharmaceutical industry experience in drug development or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 5 years directly related experience supporting drug development in a quality/compliance function /applicable compliance field.
• Knowledge of QMS and CAPA related processes and systems is required.
• Working knowledge of applicable US FDA, EU and ICH regulatory requirements and guidelines as applicable to clinical research.
• Proficient use of software packages including Excel, Word, PowerPoint, & CRM systems
• This is a part-time position (16 hours a week) in San Francisco.
Your application was submitted successfully.