4+ years of overall work experience in Pharma and Banking domains.
2+ years of experience working with Research Organizations, expertly gathering and analyzing data for highly confidential clinical trials (Amgen)
Advanced skills in EDC systems, well-versed in cGCP and FDA standards and regulations, and knowledgeable in therapeutic indications.
Knowledge of data management practices and adhering to Protocol-Specifications.
Familiar with the guidelines of reviewing and evaluating clinical data Experience with industry standard clinical data management systems (Oracle Clinical, Clintrial, RDC)
Working Knowledge of EDC using RAVE, UAT testing and MeDRA coding
Excellent team player and proven track record working in various team sizes performing cross-functional roles
Knowledge of GCP/ICH Guidelines, GMP Guidelines, QA/QC procedures, FDA regulations.
Experience with industry standard Working Knowledge of EDC using RAVE tools, clinical data management systems (Oracle Clinical, Clintrial, RDC),ARGUS
Database (ANZ)-CAP (an IBM mainframe backend system)
Systems- Staff ware, Packman, SMA- System Management Application, Legal CO
MS Office (Word, Excel, PowerPoint, Outlook
to 04/2014 HSBC Banking Group Pvt. Ltd. Banking & Financial Services – Bangalore,
Performed the required KYC screening on new
premier clients by documenting and corroborating the information obtained on
the client as required by the Global KYC procedures
Gathering and analyzing CIP
documentation in accordance with regulatory and KYC requirements.
Undertook training sessions for new joiners
Associate Clinical Data Coordinator12/2011
to 11/2012 Quintiles – Bangalore,
Performed data management activities to ensure accurate, consistent and complete clinical data.
Responsible for reviewing case report form (CRF) data for accuracy and consistency as well as identify and resolve data discrepancies.
Handle the tasks of updating and reviewing data in RAVE Oracle clinical database, based on data queries.
Worked as a team member of Oracle clinical trial team to analyze and validate data.
Performs UAT for Edit Checks that are ready for user acceptance testing
Updates the Edit check status appropriately within the Data management Plan and clinical trial database (CTDB), if applicable
Communicates issues for erroneous Edit Checks to the programmer within the Data Management Plan
Safety Data reconciliation in ARGUS database Testing the validity of data in accordance with the protocol specifications.
Quality control of data processing using edit check programs in database according to DVP Discrepancy Management using DCF forms and SEC.
Medical coding using MedDRA.
Review clinical data before and after extraction for accuracy and completeness prior to data base lock.
to 04/2011 University of Manchester – Faculty of Life Science
Worked as Research intern on mammalian target of Rapamycin (mTOR), a key
signaling pathway involved in age related disease like Cancer.
Understanding how dysregulation of the mTor protein kinase-signaling
pathway can lead to tumor formation.
Project aimed at studying regulatory proteins that modulate the
functions of the mTor pathway.
We aimed to uncover the molecular mechanisms on how a key regulatory
protein and its interacting partner regulate stress responses and its
implications for understanding their role in ageing and cancer.
to 08/2011 Manchester Interdisciplinary Bio Centre – Manchester,
UK United Kingdom
Developed a detailed Business-Plan to identify viable commercial
opportunity for a medical diagnostic device
Assessing and analyzing business structure and recommending suggestions
Designed a feasible strategic road-map for product development based on
product vision, value proposition and market analysis
Gathering and performing business data analysis Analyzing behavior of
market and competitors
Presented in a form
of pitch for investment, partnership and licensing of the product
Mortgage Loan Operations Analyst06/2008
to 07/2010 ANZ Australia and New Zealand Banking Group Ltd – Bangalore,
Credit Assessment and Risk Analysis preceding the grant of Mortgage
Interacting with sales consultant, frontline managers, departmental
heads through email and telephone to get the work simplified and the close
internal quality check for new joiners.
Handled Escalation e-mail.
Master of Science: Biotechnology and Enterprise2011University of Manchester-
ManchesterBiotechnology and Enterprise
Bachelor of Science: Bioltechnology, Botany, Chemistry2008Mount Carmel College-