Kruti Macwan
Senior Lead Clinical Data Scientist at Medrio- Claim this Profile
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Bio
Experience
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Medrio
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United States
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Software Development
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100 - 200 Employee
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Senior Lead Clinical Data Scientist
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Mar 2022 - Present
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Lead Clinical Data Scientist
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Aug 2020 - Mar 2022
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Veristat
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United States
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Research Services
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300 - 400 Employee
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Clincal Data Manager II
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Mar 2020 - Jul 2020
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Clinical Data Manager
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Oct 2018 - Mar 2020
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Topstone Research
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Canada
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Research Services
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1 - 100 Employee
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Clinical Data Manager I
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Jan 2016 - Oct 2018
Responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock Responsible for participating in ongoing data review throughout the conduct of the study Proactively identify and address issues that may impact the quality of the data Manage data provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance and auditing criteria Perform SAE/external data… Show more Responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock Responsible for participating in ongoing data review throughout the conduct of the study Proactively identify and address issues that may impact the quality of the data Manage data provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance and auditing criteria Perform SAE/external data reconciliation and data transfer Performs medical coding of clinical data (adverse events, concomitant medications) using standard coding dictionaries Show less Responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock Responsible for participating in ongoing data review throughout the conduct of the study Proactively identify and address issues that may impact the quality of the data Manage data provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance and auditing criteria Perform SAE/external data… Show more Responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock Responsible for participating in ongoing data review throughout the conduct of the study Proactively identify and address issues that may impact the quality of the data Manage data provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance and auditing criteria Perform SAE/external data reconciliation and data transfer Performs medical coding of clinical data (adverse events, concomitant medications) using standard coding dictionaries Show less
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AAIPharma Services Corp./ Cambridge Major Laboratories Inc (Now Part of Alcami)
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Clinical Data Operator
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Aug 2010 - Oct 2011
Entered, reviewed and processed clinical trial data to ensure the accuracy and consistency of the clinical databases including: • CRF tracking, data entry and document maintenance, and generation of queries to address found data discrepancies Performed the coding of clinical data (adverse events, concomitant medications, medical history) using standard coding dictionaries Entered, reviewed and processed clinical trial data to ensure the accuracy and consistency of the clinical databases including: • CRF tracking, data entry and document maintenance, and generation of queries to address found data discrepancies Performed the coding of clinical data (adverse events, concomitant medications, medical history) using standard coding dictionaries
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Allied Research International
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Associate, Clinical Data Management II
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May 2008 - Jun 2010
· Performing Medical coding for different clinical trial studies using WHO drug and MedDra · Extracting clinical data by using SAS program for data quality control · Entering, reviewing and processing clinical trial data to ensure the accuracy and consistency of the clinical databases · Performing Case Report Form data entry in Oracle Clinical and in PDS Express · Responsible for data cleaning including data verification, query generation and resolution · Performing Medical coding for different clinical trial studies using WHO drug and MedDra · Extracting clinical data by using SAS program for data quality control · Entering, reviewing and processing clinical trial data to ensure the accuracy and consistency of the clinical databases · Performing Case Report Form data entry in Oracle Clinical and in PDS Express · Responsible for data cleaning including data verification, query generation and resolution
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Jr. Clinical Data Manager
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Feb 2007 - May 2008
Provided clinical data management service for sponsors' projects. Responsibilities include specific duties during study start-up, maintenance and closeout phases, and focused on delivery of all necessary reports, extractions and clean database (DB) according to scheduled study timelines and industry standards Provided clinical data management service for sponsors' projects. Responsibilities include specific duties during study start-up, maintenance and closeout phases, and focused on delivery of all necessary reports, extractions and clean database (DB) according to scheduled study timelines and industry standards
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Clinical Data Associate
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2006 - Feb 2007
· Performing Case Report Form data entry in Oracle Clinical and in PDS Express · Responsible for data cleaning including data verification, query generation and resolution · Maintaining electronic data transfers from Central labs: blood, chemistry, hematology · Screening study databases for adherence to protocol and project specific guidelines · Filing, photocopying, scanning and collating necessary documentation associated with projects. · Performing Case Report Form data entry in Oracle Clinical and in PDS Express · Responsible for data cleaning including data verification, query generation and resolution · Maintaining electronic data transfers from Central labs: blood, chemistry, hematology · Screening study databases for adherence to protocol and project specific guidelines · Filing, photocopying, scanning and collating necessary documentation associated with projects.
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Education
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Gujarat University
Bachelors in Science, Microbiology -
Veer Narmad South Gujarat University, Surat
Post Graduate in Medical Laboratoy Technology (PGDMLT), Microbiology, General -
Toronto School Board Skills for Change
Medical Terminology Certification -
Bachelors in Microbiology, PGDMLT