Officer/Executive – QA | Clinical Data Management | Lambda Therapeutics

Job Description

  • Review of SOPs pertaining to Clinical Data Management (CDM) and preparation and review of SOPs pertaining to Quality Assurance
  • Audit of the clinical database and clinical data management documents (before database lock).
  • Calculate 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.
  • Review of Data Management Plan (DMP), Statistical Analysis Plan (SAP-clinical data management aspects) and e-CRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutic Research Ltd.
  • Conduct System audit of Clinical Data Management and preparation of audit report.
  • Review of TMF, SMF, and Site selection visit report, IMP release checklist.
  • Update Head-QA/Designee regularly on the level of compliance issues
  • To determine whether all trial-related activities were conducted, data recorded, analyzed, and reported accurately & in compliance with all applicable Regulatory requirements, Organizational requirements (Policy,
  • Procedures and processes) and Client’s requirements (protocol, contract, etc.) by routinely conducting audits at the site for all assigned projects.
  • Any other responsibilities as assigned by the Management / HOD

Qualification: B.Sc, B.Pharma