CDM QA Auditor

• To perform the role as a clinical data management (CDM) - QA auditor and be responsible for QA review or audits for clinical data management activities for BA/BE studies, phase I, II, III and IV studies
• To verify and assure compliance with ICH-GCP (R2), study protocol, study data management plan (DMP)and other applicable regulatory requirements.
• To perform QA review of study set up requirements such as CRF review and data base annotations in EDC platforms to assure study protocol requirements are fulfilled for phase I, II, III and IV studies.
• To perform QA review of study specific requirements, regarding CDISC and study data standards.
• Vendor/sub-contractor qualification/surveillance audits (onsite/remote) and provide updates on audit outcome/closeout status and follow-up as indicated.
• Effectively plan & collaborate co-audits with compliance QA team to conduct scheduled & unscheduled QA system audits
• Follow-up of study/client/sponsor audits: Collaborate with the appropriate CDM Operations team members in follow-up, to the sponsor/client audits to ensure resolution of audit findings 
• Facilitate clinical trial sponsor audits for clinical data management 
• Facilitate clinical trial regulatory inspections clinical data management 
• Plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and Syngene/Sponsor procedures, independently or with minimal supervision. 
• Travel nationally /internationally for QA audits as required. 
• Perform audits/review of qualification & validation documentation of computer systems, as required.
• Provide support & resources for regulatory inspections & sponsor audits.

• Experience in Clinical Data Management, Review of BA/BE Studies and reports, Phase I, II, III and IV studies, GLP Audits
• Familiar with regulatory guidelines and requirements like ICH-GCP (R2)

Science/ Pharmacy graduates, post graduates