Summary
Overview
Work History
Education
Skills
Websites
Timeline
Generic

Sudhir Ghawade

Hyderabad

Summary

I hold a Master's degree in Pharmacology and have extensive 11+years of experience as a Senior Clinical Data Management Scientist. My expertise includes Clinical Data Management, Data Validation and analyzing data in different therapeutic areas like Oncology, Hematology, Immunology, Cardiovascular, Dermatology and Cell & Gene therapy. I excel in ensuring the integrity and accuracy of clinical data through meticulous validation and cleaning processes. With a strong background in leading data management projects, I am proficient in utilizing advanced data management systems to support clinical trials. My proactive approach and effective communication skills make me a reliable primary contact in collaborative settings.

Overview

12
12
years of professional experience

Work History

Protocol Data Manager

Accenture Technology solution Pvt. Ltd
08.2020 - Current
  • Management and Oversight of study start-up and close-out activities (as applicable per scope) in various aspects of Data Management for a clinical trial to ensure consistency high standard database(s) delivery with respect to quality and timelines.
  • Identify and document risks and issues for study start up activities, develop mitigation plans and share with client, if required.
  • Share study plan and timelines with tower lead and work with lead to allocate Accenture resources to study, as and when required.
  • Develop Data Management Plan including study specific data cleaning listings.
  • Develop various documents during set up phase of the study (e.g. procedure/edit check specifications, Database Specification, Dynamic Matrices Specification) as applicable.
  • Review test migration and production audit trail reports for Rave.
  • To support for Data Management and study start up (DMSSU) activities, collaborate with Database Developer team as well as build and testing team, CF programmer to support overall eCRF build, programming and UAT of edit checks as well as UAT testing of CRF.
  • Attend study meetings to review database screens and other study start up meetings as needed.
  • Co-ordinate activities of Data Managers, both internally and externally stakeholders.
  • Review timelines for migration/PPC, study DB lock and provide inputs regarding activities to client.
  • Review timelines and provide inputs regarding activities to client.
  • Represent in audits and inspections maintaining documentations audit readiness all time.
  • Host the monthly study data quality meeting and present slides of study trial health to the client and all external stakeholders.
  • Worked on 15+ studies as a lead DM for medium to large-sized projects in phase I to IV clinical studies.
  • Provided data management decisions and propose strategies at the study level.

Senior Clinical Data Coordinator

IQVIA RDS (India) Pvt. Ltd
01.2019 - 07.2020
  • Acted as Functional Lead for Data Management on full-service contracts, primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups.
  • Monitored and communicated project progress to the customer and project team including use of project status reports and tracking tools/metrics.
  • Planned and managed resources as required for assigned studies.
  • Regularly reviewed project file and ensured that all filing is up to date.
  • Provided process specific training deliverables for DMs within multiple platforms.
  • Participated in, and presented at internal, customer, third-party, and investigator Meetings.
  • Performed the peer QC of the studies to across team to improve the quality of data.

Senior Process Associate

Tata Consultancy Services
09.2015 - 01.2019
  • Worked on all Study set up activities. It includes the preparation of eCRF specifications, EDC Specification, Completion Guidelines, Data Validation Specifications, test scripts writing, DMP, DQRP etc.
  • Performed set up of Oncology and Immunology Studies with collaboration with rave DBD and SAS programmer.
  • Coordinated and participated in the development of the CRF (eCRF) according to the specifications.
  • Performing the UAT of the edit checks built in system and rectifying it.
  • Handled the whole study migration activities responsibly in collaboration with the programmers.
  • Coordinated the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
  • Performed activities on reconciliation like External data, SAE reconciliation, non eCRF data, IVRS, Pharmacokinetic data Reconciliation.

Junior Data Analyst

Cognizant technology Solutions
06.2013 - 08.2015
  • Worked as a clinical data manager to perform data management activities to ensure and improve the quality of the clinical data from ongoing Clinical Trials at the client sites all over the globe.
  • Expertise in CRF Tracking, Data Entry (Single & Double Data entry) and Verification.
  • Execute Data Management activities viz. Data cleaning, Executing Manual & System Checks, update relevant trackers, Data entry as assigned.
  • Assist in maintaining protocol level documentation of data management activities.
  • Understanding study protocols and SOPs.
  • IVRS and SAE Reconciliation.

Education

M. Pharm -

Vidyabharati College of Pharmacy
Amravati, India
10.2012

B. Pharm -

Pataldhamal Wadhwani College of Pharmacy
Yavatmal, India
06.2010

H.S.C. Examination -

Anglo Hindi Junior College
Yavatmal, India
02.2005

S.S.C. Examination -

Loknayak Bapuji Aney Vidyalay
Yavatmal, India
03.2003

Skills

  • Good Clinical Practices
  • Data Analysis
  • Project Management
  • Data Integration
  • Team Management
  • Data Architecture
  • Quality Management
  • Data Quality
  • Clinical Data Management
  • Risk Management
  • Collaboration and Innovation
  • Data Strategy

Timeline

Protocol Data Manager

Accenture Technology solution Pvt. Ltd
08.2020 - Current

Senior Clinical Data Coordinator

IQVIA RDS (India) Pvt. Ltd
01.2019 - 07.2020

Senior Process Associate

Tata Consultancy Services
09.2015 - 01.2019

Junior Data Analyst

Cognizant technology Solutions
06.2013 - 08.2015

M. Pharm -

Vidyabharati College of Pharmacy

B. Pharm -

Pataldhamal Wadhwani College of Pharmacy

H.S.C. Examination -

Anglo Hindi Junior College

S.S.C. Examination -

Loknayak Bapuji Aney Vidyalay

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Sudhir Ghawade