Summary
Overview
Work History
Education
Skills
Venkataram Reddy
Timeline
Generic

K. VENKATARAMI REDDY

Clinical Research Quality Assurance-Deputy Manager
Hyderabad,Telangana

Summary

  • EXPERIANCE SUMMARY: Ten Plus years of experience in designing and conducting various phase of audits / monitoring of Clinical Trial and Pharmacokinetic studies. Expertise in handling multiple projects simultaneously and responding to various regulatory queries and ad-hoc requests.

Overview

7
7
years of post-secondary education
11
11
years of professional experience

Work History

Deputy Manager

Axis Clinicals Ltd
Hyderabad, INDIA
08.2017 - Current
  • Review and finalization of the clinical trial protocol, ICF, CRF and related logs/forms.
  • Perform the vendor qualification for IMP management, Randomization Management (IWRS), Electronic CRF (eCRF), Laboratory & Logistics services.
  • Review and finalization of regulatory submission documents for NOC and notifications.
  • Quality assurance plan preparation for each project, as per sponsor’s agreement /Study complexity.
  • Review the process of eCRF preparation i.e UAT Performance.
  • Datasets & clinical report review for finalization.
  • SOP training Management.
  • Handling of deviations & CAPAs.
  • Statistical analytical plan (SAP) review and finalization.
  • Integrated clinical report review and finalization.
  • Handling of sponsor audits and supporting to regulatory audits.
  • Assigning the auditors for site audits.
  • Perform Site Audits & preparation of audit reports.
  • Review the subordinates audit report and its compliance report for finalization.
  • Reporting to Head quality assurance about clinical trial studies status.

Sr. Executive

Aizant Drug Research solutions Pvt. Ltd
Hyderabad, INDIA
10.2015 - 08.2017
  • Performed audits for Multi centric Patient population and in-house bio equivalence studies.
  • Scheduled site audits, Prepared Audit Reports and performed compliance verification.
  • Performed checking and issuing of clinical trial related label sheets and applicable forms.
  • Release of the subject concentration to the bio-statistics department for further analysis and report generation.
  • Provided Support to Quality head in sponsor and regulatory audits.
  • Review of instrument /equipment qualification documents, calibration records.
  • Performed periodic internal diagnostics laboratory Audit.
  • Clinical Study Report (CSR) verification.
  • Submission of QA documents for Archival.

Sr. Research Associate

Hetero Labs Pvt. Ltd
Hyderabad, INDIA
08.2010 - 10.2015
  • Train, supervise & evaluate clinical research coordinators and research assistant in the performance of their duties.
  • Update training module and re-train study staff as required.
  • Performed site monitoring and report preparation.
  • Preparation and maintaining the TMF file.
  • Review Paper CRF/eCRF and source data for completeness and perform source document verification.
  • Bio samples management and logistics.
  • Close-Out:.
  • Ensure any outstanding documentation is filed (including drug accountability and destruction records) and archive project files according to company SOPs.
  • Arrange Close-Out visits with sites and organize on-site or off-site archiving; document activities in a Close-Out (Final) Monitoring Report.
  • Responsible for complete project life cycle from Site selection to Regulatory Submission Regulatory affairs:.
  • Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents.
  • Clinical Trial and Bioequivalence NOC Application documents Submission to DCGI.
  • Ethics committee dossier preparation and submission.
  • Notify to DCGI for Additional site initiation in Trials.
  • Notify to DCGI about amendments.
  • Preparation of files to submission for export BE NOC.

Education

M. Pharmacy - Pharmacology

Ultra-College of Pharmacy (M.G.R Medical University
01.2008 - 01.2010

B. Pharmacy - undefined

VL College of Pharmacy Rajiv Gandhi University
01.2002 - 01.2007

Skills

    Quality assurance plan preparation

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Venkataram Reddy

I am Pharmaceutical, Clinical research professional working in india

Timeline

Deputy Manager

Axis Clinicals Ltd
08.2017 - Current

Sr. Executive

Aizant Drug Research solutions Pvt. Ltd
10.2015 - 08.2017

Sr. Research Associate

Hetero Labs Pvt. Ltd
08.2010 - 10.2015

M. Pharmacy - Pharmacology

Ultra-College of Pharmacy (M.G.R Medical University
01.2008 - 01.2010

B. Pharmacy - undefined

VL College of Pharmacy Rajiv Gandhi University
01.2002 - 01.2007

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K. VENKATARAMI REDDYClinical Research Quality Assurance-Deputy Manager