Clinical Quality Management Specialist
Piper Companies · United States · 1 wk ago
RemoteRemoteQuality AssuranceFull-time
Piper Companies is seeking a Clinical Quality Management Specialist (CQMS) to support a clinical research organization managing government-funded clinical research programs, including NIH and NIAID studies. This position is hybrid; candidates must reside within the DMV area.
Responsibilities
- Support the review, maintenance, and continuous improvement of Clinical Quality Management Plans (CQMPs).
- Provide quality and compliance guidance to clinical research sites, study teams, and stakeholders.
- Maintain quality metrics, site performance indicators, and clinical performance tracking systems.
- Assist with the development and maintenance of quality reports, dashboards, and compliance reporting tools.
- Support SOP development, revisions, and quality process documentation initiatives.
- Conduct data verification, quality reviews, and system validation activities to ensure data integrity and compliance.
- Participate in audits, inspections, CAPA activities, and inspection readiness efforts while collaborating with cross-functional teams.
Requirements
- 2–5 years of experience in Clinical Quality, Clinical Research, Clinical Operations, Quality Assurance, or a related regulated healthcare/life sciences environment.
- Working knowledge of ICH-GCP guidelines and clinical research regulations.
- 2–5 years of experience supporting Clinical Quality Management Systems (CQMS), audits, inspections, quality metrics, CAPA management, and quality process improvement initiatives.
- Experience supporting quality metrics, compliance reporting, or clinical performance tracking systems.
- Strong proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
- Bachelor's degree in Life Sciences, Biology, Healthcare, Public Health, or a related scientific discipline; equivalent experience considered.
Pay
Salary Range: $72,800–$83,200 annually (based on experience).
Benefits
- Paid Time Off (PTO).
- Paid Holidays.
- Medical, Dental, and Vision insurance.
- 401K retirement plan.
- Tuition Reimbursement.
- Paid Maternity Leave.
- Military Reserve Pay Offset.