Key Qualifications
  • Minimum 7 years of experience with good clinical practice (GCP) working in clinical compliance, quality management systems, or in a clinical functional area such as clinical operations or clinical data management
  • Minimum 2 years of experience and/or transferable skills in QA and regulatory inspections
  • Strong knowledge of ICH guidelines and understanding of current regulatory requirements (FDA, EMA, MHRA, etc.) related/applicable to the conduct of clinical trials
  • Strong quality foundation to manage the deviation and CAPA development

Position Summary
The Clinical Data Science (CDS) Quality Specialist is a full-time placement that is fully integrated within a major pharmaceutical company. The assignment is for a minimum of 6 months with possible extensions or placement in other roles for Trialwise and its clients.

The embedded CDS Quality Specialist will be the lead on (1) the development and implementation of the quality control (QC) integration management, and (2) managing the sponsor internal quality incident management in partnership with CDS stakeholders and sponsor R&D quality and medical governance (R&D Q&MG). The CDS Quality Specialist will employ a proactive approach in developing and implementing QC processes to continuously assess the quality of CDS operations, identifying process and/or procedural improvement opportunities, and building overall quality measurement within CDS.

Core Responsibilities
Manage and oversee the internal quality incident management for CDS through monitoring of complaints, deviations, and CAPAs. Activities include but are not limited to:
  • Manage non-compliance including deviation determination in consultation with sponsor R&D Q&MG, and CDS stakeholders
  • Coordinate and participate directly in the investigation of deviations, noncompliance, CAPA planning
  • Facilitate a thorough and credible root cause analysis and CAPA discussion, including the development of a corrective action or preventive action for sentinel events
  • Manage and coordinate QC activities, including schedule, QC plan, conduct QC, written QC findings, and post-QC follow-up activities to ensure that non-compliance issues are addressed with satisfactory resolution
  • Document detailed QC findings and recommendations in a timely manner that allows for proper review and assessment of identified issues and/or risks
  • Review QC findings with identified CDS subject matter experts (SMEs) and clearly communicate QC results and compliance risk to therapeutic area heads and/or delegate
  • Collect data on QC findings, prepare comprehensive QC metric reports, and analyze trends to identify process gaps and direct quality improvement and training initiatives
  • Present data trends and risk assessment to the applicable CDS therapeutic area heads and/or delegate
  • Identify areas for continuous improvement by providing feedback on CDS processes
  • Looks for opportunities to expand breadth and depth of quality control, corrective actions, and/or clinical research experience
  • Assists the cross-functional team when possible
  • Provides outstanding customer service
  • Maintains a positive outlook and a growth mindset in all work activities
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Corporate Location
Foster City, CA. This role is US remote-based (home office) with travel as required.

Cover Letter Required
Only CVs accompanied by a cover letter will be considered. Please describe how your clinical experience and skills meet the Key Qualifications for this position.