Roles & Responsibilities
• Conduct in-process, on-site, and off-site audits to ensure trial activities are performed, recorded, analyzed, and reported in compliance with regulatory, organizational, and client requirements
• Perform system audits as per the annual audit calendar to ensure compliance with Lambda SOPs, quality systems, protocols, and applicable regulations
• Carry out retrospective audits of study raw data including ICFs, protocols, project management plans, IMP plans and release checklists, SMPs, CSRs, and medical imaging documents
• Support completion of assigned system audits and preparation of detailed audit reports
• Review and contribute to SOPs related to Clinical Data Management and Quality Assurance
• Audit clinical databases and CDM documents prior to database lock
• Calculate clinical database error rates and communicate findings to CDM; prepare CDM audit status for audit certificates and QA statements
• Review Data Management Plans, SAPs (CDM aspects), and CRF/eCRF designs for assigned projects
• Conduct system audits of Clinical Data Management functions and report outcomes
• Review TMF, SMF, site selection visit reports, and IMP release documentation
Qualification
• M.Pharm
Experience
• 2-3 years of experience in late-phase Quality Assurance within clinical research
Skills
• Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial quality systems
• Experience in CDM audits, database reviews, and SOP compliance
• High attention to detail with strong analytical and reporting skills
• Effective communication and documentation abilities
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization headquartered in Ahmedabad, India, with operations across India, the USA, Canada, Europe, and the UK, delivering end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.