1. NAMITHA RAJASHEKAR
Mobile: +919886929898 Email: nithu.r3@gmail.com
To work on challenging assignments in a professional environment and reach new heights with dedication and hard
work and in turn contribute significantly to the development of the organization.
Brief Introduction about Experience
4.0 years of total experience in Database Design and 1.5 in Spotfire.
Expertise in Medidata Rave and the Data flow in and out of the system.
Understanding of Clinical Research operations and holds good knowledge on various therapeutic areas.
Research Projects from UAT to closeout with appreciable timeline sensitivity.
Expertise in TIBCO Products Suite – TIBCO Spotfire Professional, Spotfire Webplayer and basic knowledge of
TIBCO Spotfire Server.
Healthcare/Technical Services Professional capable of handling analytical requirements of clinical research.
Profeicient in Inform ecrf and building, programming structure of the edit checks.
Good knowledge of SQL and HTML.
PROFESSIONAL CREDENTIALS
Current Organisation: Pharm-Olam International
Work Experience: Jan2016- till now
Designation: Data System Designer
Job Role: Provide data in various formats and applications to data management customers, per client
specifications.
Analysing Data andprojecting invarious graphformat using TibcoSpotfire.
Provide programming or other support and assistance to CDM managers/ Project Lead.
Assisting Data Managers with status reports.
Coordinate reviews with the requestor of the study.
Coordinating with theSAS tools and running reports using codes if required.
May providetechnical expertise to project teams in the operational aspects of DataSystems and
support, ensuringconsistency among systems to avoid redundancy, inefficiency, or potential
problems; and keeps current with technology trends as they affect data systems management.
Demonstrates a working knowledge of protocol
Analysing Data and projecting in various graph format using Tibco Spotfire.
Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules,
data structures, data libraries, code lists, and dictionaries in conjunction with input from other
functional areas and project teams and in accordance with CDISC standards.
Performs the integration / consolidation and archival of databases in accordance with applicable
client and / or regulatory guidelines. Support and ensure thepreparation, transfer and integration
of clinical data from internal and external sources into the study database.
Supports studies with User Administration tasks.
2. Pervious Organisation: Quintiles (CRO)
Work Experience: Dec2013 – Dec2015
Designation: SpotFire Programmer (Jun-2014 to Dec2015)
Client AMGEN
Job Role: Plan and coordinate database design, development, implementation, maintenance, and user
support of clinical systems.
Program and test in accordance with programming standards and validation procedures as per
the SOPs provided.
To program reports/packages.
Coordinate and communicate with theCDM (Clinical DataManagement) team.
Information Link Development.
Spotfire Library Administration.
Provide programming or other support and assistance to CDM managers/ Project Lead.
Assisting DataManagers with status reports.
Coordinate reviews with the requestor of the study.
May assist IT in testing new upgrades to technologies.
To facilitate team member transition to Spotfireprocess.
Meet objectives as assigned, and interact with the project team to organize timelines,
responsibilities and deliverables.
Designation: Rave Programmer (Dec-2013 to Dec2015)
Client AMGEN
Job Role: To support design and programming of data entry interface, data structures and quality rules for
assigned projects and studies. Setup of Data Systemfor study conducts (e.g. data quality checks,
validity tool, coding call, SAE etc.)
Provide data in various formats and applications to data management customers, per client
specifications.
May providetechnical expertise to project teams in the operational aspects of DataSystems and
support, ensuringconsistency among systems to avoid redundancy, inefficiency, or potential
problems; and keeps current with technology trends as they affect data systems management.
Demonstrates a working knowledge of protocol
Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules,
data structures, data libraries, code lists, and dictionaries in conjunction with input from other
functional areas and project teams and in accordance with CDISC standards.
Performs the integration / consolidation and archival of databases in accordance with applicable
client and / or regulatory guidelines. Support and ensure thepreparation, transfer and integration
of clinical data from internal and external sources into the study database.
Supports studies with User Administration tasks.
Pervious Organisation: Accenture Services Pvt. Ltd. , Bangalore
Work Experience: Jul2012 – Dec2013
Current Designation: Clinical Database Developer (INFORM) ( Accenture Pharmaceutical Services)
Client Merck
Job Role: CDS Developer develops electronic systems for clinical data capture and
management, focusing on eCRF creation, edit check and business logic required to
complete the study.
Demonstrates a working knowledge of protocol
Participates in the preparation of CDS activities for investigatormeetings
Develops working knowledge of Clinical Database Development tools
Develops working knowledge of database standards and study development process
Participates in gathering requirements for third party data
Participates in UAT
3. Clinical database development activities, including protocolreview, CRF/eCRF
design,database discrepancy criteria, database development and testing
IT PROFICIENCY
Languages: C#,Python,VB.net,Advanced HTML
Database: Advanced SQL
Operating Systems: Windows 9X/2000/Xp/7.
Project
Internal Project with the Quintiles on Designing the Dashboard for the Team/Preparing visualization based on
the team performance of month on month data.
Certifications
Amgen Spotfire Certified
Inform Certified
Rave Certified
GCP/IP Certified
ACADEMIC CREDENTIALS
2012 BCA from Vivekananda Degree college,Bangalore with 78%.
2008 12th from Vijaya Bharathi college,Bangalorewith 68%.
Currently PursuingMCA in IGNOU, Bangalore
AWARDS / ACHIEVEMENTS
Won Numero Uno Award in Accenture for the Maximize Production Delivery and Project Management.
Upraises received by many Clients regarding the Hard and efficient work in the Projects.
Received Value Added by constant performance management in the production as well as in the team engagement
activities.
Recived Special Acheviment Award for exceeding performance in Quintiles.
HOBBY
Creative Works
Music and Dance
Travelling
4. PERSONAL VITAE
Father’s name: Late N.G.Rajashekar
Date of birth: 26th May 1991
Permanent Address: #87,ShivaKrupa,14thCross,Rajagopal Nagar Main Road,Peenya II Stage,Bangalore-560058
Present Address: #192,Arun.B,1st Main,Duo Heights Layout,Begur,Bangalore-560063
Languages known: Kannada, English, Hindi, Telugu, Tamil, Malayalam.
I hereby declare that the information given is true and correct to the best of my knowledge.
Place: (NAMITHA RAJASHEKAR)