Lambda Therapeutic Research is a leading Global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland), and London (UK). The company provides end-to-end clinical research services to pharmaceutical, biotech, and generic drug industries worldwide.
Lambda is known for its high-quality clinical trials, regulatory compliance, and robust quality assurance systems, making it a preferred CRO for global clients.
Job Description: Clinical Data Management Auditor
As an Officer/Sr. Officer in Late Phase Quality Assurance, you will be responsible for ensuring compliance with regulatory standards, organizational SOPs, and client requirements through systematic audits.
Key Responsibilities:
✔ Conduct in-process, on-site, and off-site audits for clinical trials to ensure accuracy and compliance.
✔ Perform system audits as per the annual audit calendar.
✔ Audit raw clinical data including Informed Consent Forms (ICF), protocols, Clinical Study Reports (CSR), and Medical Imaging documents.
✔ Review SOPs related to Clinical Data Management (CDM) and contribute to SOP development.
✔ Audit clinical databases & data management documents before database lock.
✔ Calculate error rates in clinical databases and report findings to CDM teams.
✔ Review Data Management Plans (DMP), Statistical Analysis Plans (SAP), and e-CRF/CRF designs.
✔ Conduct system audits for CDM and prepare audit reports.
✔ Review Trial Master Files (TMF), Site Master Files (SMF), and IMP release checklists.
Required Competencies:
✅ Accountability – Strong sense of responsibility in audit processes.
✅ Communication Skills – Clear and effective verbal/written communication.
✅ Work Ethic – High integrity and commitment to quality.
✅ Presentation Skills – Ability to present audit findings professionally.
✅ Organizational Culture Fit – Adaptability to Lambda’s work environment.
