CV

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Krupa Prakash Vyas
Contact Number: +353899878238 |Email id: vkrupa0309@gmail.com
SUMMARY
A healthcare professional with quality, timelines, communication, and documentation as core competencies.
Strong Clinical Data Management experience with a master’s degree in Clinical Research from NUI Galway.
I aspire to work in a challenging environment where I can display my technical and management skills resulting
in tangible difference to the success of the organization.
SKILL SET
• Thorough knowledge of regulatory guidelines like ICH GCP
• Clinical Data Management process in therapeutic areas such as Oncology, Central Nervous System, and
Cardiovascular System
• Handled Phase I, Phase II and Phase III of Clinical Trial
• Study co-ordination activities across several countries for global studies
• Extensive exposure to CDM databases such as Inform, Rave, iDatafax and Macro
• Experience in Set up, Conduct, and Close out activities
• Team mentoring and management
• Risk Based Monitoring
EDUCATIONAL BACKGROUND
WORK EXPERIENCE
1) Role: Clinical Data Manager
Organization: HRB Clinical Research Facility- Galway, NUI-Galway
Year: September2016 to Presently
• Managing set up and conduct activities for oncology studies
• Clinical Data Processing: Data entry and CRF tracking management
• Creating and maintaining monthly patient recruitment metrics
• User Access Management
• Risk Based Monitoring
Achievements: Conferred with a fellowship by HRB Clinical Research Facility- Galway, NUI Galway
2) Role: Clinical Data Manager
Organization: Cognizant Technology Solutions Private Limited India
Year: From May 2014 to June 2016
• Set up activities- Creating DVS and study specifications, creating eCRF completion guidelines,
developing test cases and performing UAT, post production database modification.
YEAR DEGREE INSTITUTION GRADE
2016-2017 MSc in Clinical Research National University of
Ireland – Galway, Ireland
Expected in 2017
2012-2014 MSc in Biotechnology St. Xavier’s College
(Autonomous)- Mumbai
University, India
First Class with
Distinction
2009-2012 BSc in Biotechnology Mithibai College- The
University of Mumbai
University, India
First Class with
Distinction

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• Conduct activities- Query Management, Manual review, External Data Reconciliation (ECG, LAB and
IVRS), SAE Reconciliation, listing review for DSMB, IDRP and Safety meeting reports
• Close out activities- Final data review and cleaning, contributed to timebound lock of a study.
Handled post lock clinical documentation and archival in compliance with SOP and GCP
• Senior Clinical Data Manager for a Phase III study:
➢ Mentoring team members, conducting protocol understanding and knowledge transfer sessions
on a regular basis
➢ Performing a peer Quality Check for all the activities and tracking the defects
➢ Co-ordinating with the study team for resolution of outstanding queries and doing a routine
follow-up for updates
➢ Handling production defects in live environment and new client requests through a standard
Change Request process
➢ Participating in DSMB, IDRP and Safety Review meetings as a DM representative
➢ Creating study data deck and metrics for global meetings
➢ User Access Management
➢ Faced an internal and an external audit respectively
➢ Participation in conference call with the study team
➢ Creation of TMF
➢ Undergoing training such as 'Quality Control and Application of Six Sigma tools for Quality
Management' and 'SDTM Process Overview and Understanding'.
Achievements:
• Awarded for ‘Spearheading High Performance and quality’ at Cognizant Technology Solutions-2016
• Awarded for excellent contribution and consistent dedicated work at Cognizant Technology Solutions-
2015
• Handling a study with no major escalations throughout the tenure
• Introduction of team metrics and tracker to manage both timelines and quality
INTERNSHIP
• Biotechnology: Intern at SRL-Ltd (Mumbai, India) for MSc Dissertation.
Year: November 2013- February 2014
Project title: Molecular analysis of PDGFRA gene exon 12 mutations in Gastrointestinal Stromal Tumors
in Indian patients.
I have worked on molecular analysis of PDGFRA gene mutations in Gastrointestinal Stromal Tumors. It
involved screening of mutations using molecular biology techniques followed by statistical correlation
to the clinicopathological data.
EXTRA CURRICULAR ACTIVITIES
• NUI Galway International Student Ambassador for India (2016-2017).
• Developing a Risk Based Monitoring tool
• Head of the Creative Department- St. Xavier's College.
• Certificate course on Information Communication Technology Skills Development Education from
Department of lifelong Extension-Mumbai University. Topics covered: Women Empowerment,
Population Education, and Open Schooling.
REFERENCE
Available on Request.