Clinical systems validation

Harish Pedanati

H.No *-*-***, Indira Nagar, Manugur, Khammam(Dt), Telangana 507117

Ph.No : 949*******, 961-***-**** Email Id :******.********@*****.***

Functional Consultant (e-clinical)

3.9 years of experience working with a Contract Research Organizations (CRO) and Life Sciences Consulting &Technology Service provider, expertly gathering and analyzing data for highly confidential clinical trials.

Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the Software Development lifecycle.

Advanced skills in EDC systems, study hypothesis, well-versed in cGCP and FDA standards and regulations, and knowledgeable in various therapeutic indications.

Professional Experience

TECHSOL SYSTEMS INDIA PVT. LTD

Validation Functional Consultant, E-Clinical Solutions, April 2014 – Till Now

Over 1.3 years of experience in Software Quality Assurance, Business Analysis,Validation and Testing providing a well-balanced understanding of business relationships, business requirements, and technical solutions.

Analytical, methodical, and resourceful approach to problem solving, identifying and documenting root causes and corrective actions to meet short and long-term business and system requirements.

Excellent hands-on experience in all phases of testing including Preparation of Test Plans, Reusable Test Strategies, Test Scripts, Traceability Matrix, and Test Summary Reports for executing test scripts according to SOPs.

Good understanding of the System Development Life Cycle and Testing Methodologies.

Experience in validation of Oracle Clinical, RDC, and TMS, Siebel CTMS.

Experience in creating the Validation Protocols (OQ, PQ), Test Plans, and Test Scripts.

Experience in developing and reviewing User Requirements Specification (URS) and Functional Requirements Specification (FRS) documents.

Good working experience in FDA regulated environment including 21CFR part11. Good working Knowledge of the GMP, GCP, GLP and GDP standards.

Managed meetings to review FDA validation protocols and procedures regarding 21 CFR part 11 guidance for the industry.

Experience in tracking and resolving defects using Test Director by working closely with Developers throughout Software Defect Life Cycle.

Developed quality control systems to ensure proper tracking of documentation in conjunction with FDA requirements.

Worked closely with designers and developers in planning, scheduling, developing, and executing system level as well as integration tests for software application.

Thorough Knowledge and experience of Microsoft Office tools like MS word, MS Excel, MS Access, MS Project and MS PowerPoint.

PAREXEL INTERNATIONAL INDIA PVT.LTD

Clinical Data Analyst, 2011 to 2014 April

Support clinical trials for CRO by providing meticulous data management. Design and maintain databases, queries, reports, and graphics and data-analysis tools; perform data entry, check reviews, database audits and coding; and define and validate study protocols.

Interpret, synthesize and present technical information to CRO management and pharmaceutical and biotechnology clients.

Work closely with Oracle Clinical developers on the design, testing and implementation of study databases.

Oversee data-management lifecycle of large clinical trials, composing and verifying reports and results.

Develop clear clinical data sets enabling the standardized collection and analysis of massive amounts of cross-boundary data content in a timely manner and with a high level of accuracy.

Track progress of clinical studies, ensuring projects meet timelines and quality expectations.

Quickly mastered industry best practices in CRO clinical-study procedures and data management.

Excelled in managing high-priority projects and resolving data discrepancies, errors and omissions with thoroughness and expedience.

Facilitated the rollout of new EDC system that streamlined data entry and improved data-analysis functions. Contributed to design and development of new GUIs, validation components and reporting tools.

Education

Masters in Pharmacy (Pharmacology) JNTU Anantapur,2011.

SAS Certified in Clinical Trail Programming.

Technology Summary

FDA Regulations / Validation Protocols: 21CFR Part 11, 210/ 211, 810, 820, cGxP (cGCP), URS, FRS, RTM, OQ, PQ, SOPs, VMPs, VSRs.

Clinical Applications: Oracle Clinical, RDC, TMS, Siebel, Inform, SAS and Open Clinica

Operating Systems: Windows and UNIX

Testing Tools: Manual Testing

Version Control/ Document Management Systems: ZOHO.

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