Executive

• Plan and carry out In-process audits of study activities in Clinical Pharmacology Medical Affairs department like Alco/Urine scan, informed consent presentation, compliance check, check-in, dosing, meal distribution, phlebotomy, dispensing, Sample separation etc.
• Conduct retrospective audits of study related raw data like Informed Consent Forms, Medical Screening records, Trial Master File, Investigation Medicinal Product forms, Clinical raw data like Case Record Forms, General Case Record Forms, listings in case of e-CRF studies, PK PD Projects etc.
• Review of Clinical Pharmacology and Medical Affairs, Quality Assurance, Biostatistics Programming and other cross functional department SOPs for correctness, adequacy and completeness.
• Conduct retrospective review of Clinical Study Report, PK/statistical study report and clinical study protocol.
• Conduct system audit as per schedule, preparation of audit report and ensuring compliance in Clinical Pharmacology Medical Affairs, Biostatistics Programming and other cross functional department.
• Review of incident report, investigation report, Statistical Analysis Plan (SAP) or other study specific documents.
• Review of sponsor comments Monitoring observation responses.
• Conduct the dossier verification for correctness and completeness.
• Preparation of Audit Certificate/Quality Assurance Statement.
• Uploading of QA related documents in e-TMF software.
• Review of uploaded data in e-TMF software.
• Conduct the vendor audits who are service providers to assess compliance.
• Providing support in sponsor and regulatory inspections.
• To perform QA functions as per OECD GLP principles and to ensure its compliance.
• Any other responsibilities as assigned by the management / HOD.

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