What are the responsibilities and job description for the Lead Clinical Quality Assurance Manager position at SciPro Inc.?
Lead Clinical Quality Assurance Manager
We are looking for an experienced and proactive individual to drive quality assurance in our clinical operations.
Key Responsibilities
- Develop and implement strong GCP systems and processes in partnership with the clinical operations team.
- Support Clinical Quality Assurance (CQA) initiatives, including Trial Master File (TMF) management and site audit activities.
- Work closely with clinical teams to ensure compliance with Good Clinical Practice (GCP) standards and internal clinical trial protocols.
- Lead efforts in clinical program planning and execution, including conducting protocol reviews, evaluating informed consent forms (ICFs), implementing corrective and preventive actions (CAPAs), and preparing clinical study reports (CSRs).
- Provide oversight for clinical trial partners such as Clinical Research Organizations (CROs) and contractors, and assist in the selection and onboarding of new third-party vendors.
- Manage the qualification and continuous assessment of GxP suppliers, ensuring that significant findings are reported to Quality Management and relevant stakeholders.
- Review clinical agreements to clarify roles, responsibilities, and communication protocols related to quality tasks.
- Conduct both internal and external audits, lead the investigation of findings, and supervise corrective / preventive actions, including root cause analysis and effectiveness checks.
Qualifications and Skills
Location : [Insert Address]
