Job Description

Role & responsibilities 1. To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Clients requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects 2. Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements 3. Support Head-QA/Designee for handling regulatory inspections, Sponsor system audit, arranging data for regulatory inspection, Sponsor system audit 4. Provide Audit and inspection support for assigned projects including where feasible, advising the project team during preparation and conduct of external audits and inspection 5. To perform retrospective audits of study related raw data like Informed Consent Forms, protocol, project management plan and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report, Medical Imaging related documents 6. Prepare and review of QA SOPs, review of system SOPs (CTM, MI, CTM-MS) and working instructions of other department (Clinical Trial Management) for correctness, adequacy and compliance 7. After completion of all the stages of audit for undertaken clinical trial, prepare the risk analysis of observations and suggest mitigation plan to concerned department and to share the report with management 8. To review and provide inputs to sponsor query responses and facilitate regulatory inspections at site in conjunction with operation team (as applicable) 9. Planning and communications for On-site audit for all applicable projects, vendor audit Management 10. Compilation of the data and updation of internal tracker/database at regular interval to perform trend analysis 11. Audits of Trial Master File, Site Master File, Protocol deviation tracker and SAE tracker at various stages of the clinical trial 12. Process Owner of Training Management System 13. Update Head-QA/Designee regularly on the level of compliance and compliance issues 14. Any other responsibilities as assigned by the Management/HOD 15. To assist in completion of assigned system audits 16. Audit of the clinical database and clinical data management documents (before database lock) 17. Calculation of %Error rate for the clinical database (before database lock) and issue the same to clinical data management. Prepare CDM audit status for incorporation in audit certificate/QA statement 18. Review of Data Management Plan (DMP), Statical Analysis Plan (SAP CDM aspects) and eCRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutics Research Ltd 19. Conduct System audit of Clinical Data Management and preparation of audit report Preferred candidate profile - Candidate should have minimum 4 yrs. experience in Clinical Research Organisation.