This document provides a summary of Raghavendra S's career and qualifications. It outlines his 4 years of experience in clinical data management, knowledge of FDA and CDISC guidelines, and experience handling clinical trial data from various sources. It also lists his educational background, including an MSc in Applied Genetics and BSc in Biotechnology. Raghavendra has worked for several companies, including PPD and Quintiles, managing clinical trials and databases in therapeutic areas such as oncology, cardiology, and psychiatry.

1. Raghavendra S
Contact No: +91-9945123031
Email id: jshane59@gmail.com
CAREER ABSTRACTS
 A professional with 4 years of qualitative experience in Clinical Data management
since 2012.
 Good Comprehension of FDA and CDISC guidelines, Good Clinical Practice (ICH
GCP).
 Knowledge of clinical Trial data like Demographic Data, Adverse Events (AE),
Serious Adverse Events (SAE), and Vendor Data (ePRO, PK and Lab Data).
 Knowledge of Clinical Research Methodology.
 Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice
(GCDMP).
 A thorough professional with a proactive attitude, capable of thinking in & out of
the box. Exceptional communication, presentations, counseling and mentoring
skills.
 Perform data entry and research in various systems and tracking tools. Apply
knowledge of processes and related systems to assist in identifying, assessing and
resolving issues/problems. Assess and resolve non-standard and standard issues or
problems. Seek advice and escalate issues when faced with tasks/problems outside
the scope of the work.
CAREER HIGHLIGHTS
PPD-Pharmaceutical product development, Bangalore, Dec-2015 till date
 Develop and test databases and edit specifications.
 LNR entries and start up UAT activities of EEC according to draft guidelines
 Discrepancy management in addition to Vendor reconciliation of Lab, ECG and
MRI data points
 Validate data according to CDISC and SDTM output
 Query management and periodically metrics preparation as per client
specifications.
Quintiles Technologies Pvt Ltd, Bangalore, Sep-2014 till date
 Performing as a core resource for the largest, highly expected Therapeutic area
‘Oncology’ in the organization.
 Reliable back-up to a Data Operations Coordinator of an Onco trial (sister study).

2.  Conduct data review. Write and resolve data clarifications. Develop and test
databases and edit specifications.
 Validate test steps, Test case creation, development of eCRF to meet the needs of
the customer and the clinical trial utilizing protocol and specifications provided at
the pre-design meeting.
 Understand Quintiles EDC processes and the requirements on the design for
reporting and study management.
 Advise and provide justification for design decisions to Technical Lead and at
Design Meeting.
 Responsible for optimal design reducing the number of edit checks required,
ensuring good system performance, and the utilization of global/client specific
libraries to ensure consistency.
 Draft Edit Check Specification to the DTL.
 Good communication skills and interpersonal skills, Mentor for two core resources
of different career level.
 Technically sound, logical thinker to resolve questions and issues with the
Technical Lead, DTL and VTL. This role will need to have a good knowledge of
forms design, data flow, and the impact of design on the system.
 Review and reconcile SAE with the GMS safety database vs EDC.
 Dataset validation (DTP) of the RAVE extracts in compatible with SDTM IG v1.3
 Liaise with the medical review team to analyse the potential data points facilitating
fast data cleaning process.
Accenture India Pvt Ltd, Bangalore, February-2012 to September-2014
 Review and resolve auto queries that have fired in the system. Perform manual
checks as specified in guidelines and protocol, issue manual queries and track,
review and close all query responses(Query management)
 Re-issue and close out (as required) coding queries and follow up on Field Monitor
queries during study close out and emergency situations.
 Perform lab reconciliation on received reconciliation output, issue queries and send
vendor issue spreadsheet.(External data reconciliation in coordination with the
vendors)
 Reference data issues log to resolve questions whenever possible.
 Interact with the on-shore project leads regarding data validation issues.
 Ensure timelines set by the client in terms of pages produced and clean patient
delivery are the key focus.
 Assisting team leaders in resolving complex issues.
 Ensure the completeness and validity of the clinical trial data that has been entered
in database.
 Adhered to the Business SLA and norms.

3.  Database lock procedures performed upon confirmation from the onshore PLs,
ensured with the thorough checks
 I have created the metrics reports for the deal to ensure the daily assigned task is
being accomplished on prioritize wise. This metrics report also help us the number
of backlog, the total number of FTEs working on the project also how many
backlogs have missed SLAs.
Achievements and other Activity
 Received Two Numero Uno Award for best performance with Quality in
Accenture.
 Receive Summit Awards two times for value creator and business operator in
Accenture.
 BRAVO award for leading and accomplishing the critical deliverable tracking
mechanism for Interim lock of Oncology trial.
Data Management systems experience:
 Imedidata, MEDIDATA RAVE
 Phase forward Inform 4.6
Therapeutic Areas:
 Oncology
 Cardiovascular
 Psychiatry
 Respiratory
STRENGTHS
 Ethical, compliant with company’s set forth policies
 Team facilitator
 Fast Learner
 Good at interpersonal Skills.
 Initiator and Team leading ability.
 Highly flexible.
 Willingness to learn new things with every opportunity in way.
 Microsoft office applications.

4. Key Projects Handled
 Project on study of gene and genotype frequency of Mendelian traits in human
 Population genetics and Hardy-Weinberg law sampling, data analysis, result
analysis and statistic validation, Hypothesis testing using chi-square test and t-test.
ACADEMIA
Qualification Institution University/Board Year of passing % of marks
M.sc Applied genetics Dayanand sagar
institution
Bangalore University 2011 70
B.sc Biotechnology Vijaya college,
jayanagar, Bangalore
Bangalore University 2009 70
12th (PUC) Krupanidhi pre
university, Bangalore
Karnataka state Board 2006 68
10th (SSLC) N.S.V.K Holy mother,
Bangalore
Karnataka state board 2004 78
I hereby declare that the above stated information is true to the best of my knowledge.
Place: Bangalore
RAGHAVENDRA S.
Date: 13/June/2015