Job title: Quality Control- Clinical Research Centre – Pashan, Pune

Company: GenNext Human Resource Management

Job description: QC, Quality Control,

1. Perform Quality Control of all study related source data (Registration Forms, BAT Software Data, OVIS Data, Informed Consent Documents, Trail Master File, General Case Record Documents and Subject CRFs etc.) compilation and submission of study related data to QA dept. within set timelines. 2. To confirm all the activities/ process are performed as per GCP, protocol, SOP, and applicable guidelines during study conduction. 3. Perform Quality control of protocol and appendices along with correspondence documents. 4. Check Pharmacy related documents (IP receipts, shipping, logbooks, discrepancies etc,) perform system audits whenever necessary. 5. Monitoring of outsourced bio-studies whenever notified by QA/ Project Mgmt Team/ Head. 6. Review of Final Draft CRF generated from BM Dept. and QC of study data generated by BM dept. 7. Conduct training for good documentation practices. 8. Perform quality check of Clinical Study Reports against clinical source data. 9. Ensure delivery of all clinical data to Pharmacokinetic department for regulatory submission as per eCTD specifications (Scanning, bookmarking of CRF, Protocol linking etc.) 10. Experience of conducting data review and audits in Clinical Research dept. in a consistent manner to ensure that the facility is compliant with established procedures and applicable guidelines.

Expected salary:

Location: Pune, Maharashtra

Job date: Sun, 01 May 2022 22:10:00 GMT

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