Clinical QC Consultant

Position Overview

The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards.

Key Responsibilities

• Perform QC review of clinical documents, including:
• Clinical study reports (CSRs)
• Protocols and protocol amendments
• Informed consent forms (ICFs)
• Monitoring visit reports
• Trial master file (TMF) documents
• Ensure compliance with:
• Food and Drug Administration (FDA) regulations
• International Council for Harmonisation (ICH) guidelines
• Good Clinical Practice (Google Cloud Platform) standards
• Verify data accuracy and consistency across clinical systems (e.g., EDC, CTMS, TMF)
• Identify discrepancies, errors, or missing information and communicate findings to clinical teams
• Ensure proper documentation, version control, and audit readiness
• Support inspection readiness activities and participate in internal audits
• Collaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs

• Assist in the preparation of protocols (including the writing of administrative letters for protocols and summary of changes for protocol amendments) and CSRs.
• Assist in the preparation of study-level documentation required for clinical trials (e.g., CSR appendices, shell drafts)
• Edit CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.

Required Qualifications

• Bachelor s degree in Life Sciences, Pharmacy, Nursing, or related field
• 5+ years of experience in clinical research, QA/QC, or clinical operations
• Strong knowledge of FDA regulations, ICH guidelines, and Google Cloud Platform
• Experience reviewing clinical trial documentation and TMF management
• High attention to detail and strong analytical skills

Preferred Qualifications

• Experience in hepatology or rare disease clinical trials (relevant to Intercept s focus areas)
• Prior experience in a biotech or pharmaceutical company
• Familiarity with electronic systems such as Veeva Vault, Medidata, or similar

Key Skills

• Quality control and audit readiness
• Documentation review and compliance
• Communication and collaboration