Teva Pharmaceuticals | Jobs | Quality Analyst I | BigDataKB.com | 27-03-22

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05/04/2022

Job Location: Mumbai

Candidate with experience of BizNET software application its clinical data management.

Testing of deployment for BizNET CTMS and verifying with URS

Experience with preparation review of BizNET CTM SOPs.

Experience with designing of e- CRF and screening forms for clinical studies.

Training of BizNET CTM applications to Users.

To monitor and perform Quality Check of all study activities from check-in, dosing, sample collection, processing, segregation, transfer and till checkout.

Co-ordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.

Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.

Coordinate with the Ethics Committee for submission of protocol and other study related documents.

To perform QC of ICF, compensation chart and review of CRF (versus Protocol), other study related documents prior to EC submission.

Handling of monitor s visits, maintaining of site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.

Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.

Any discrepancies/ Deviations to be informed to Team Leader and Manager (if Required).

Ensuring quality by reviewing all study related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study close out report, Sample Case record form, Study updates, screening examination record.

Full participation in internal and external audits by sponsors and other oversight entities such as FDA, EU, ANVISA.

Review of SDTM Clinic tables data with the source document.

To verify the calibration and verification of instruments/equipment.

Qualifications

Education: B. Pharm, M. Pharm or M.Sc. (Clinical Research) or any post graduate.

Experience: At least 1- 6 years of experience as a Clinical Research Coordinator in reputed BA/BE centre.

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