Summary
Overview
Work History
Education
Certification
Disclaimer
Timeline
Generic
Swapnali Sagar Sutar

Swapnali Sagar Sutar

Summary

To work in Challenging environment demanding all my skills & efforts to explore & adopt myself & realize my potential & contribute to the development of organization with impressive performance.

Overview

16
16
years of professional experience
1
1
Certification

Work History

External Data Acquisition Programmer

Tata Consultancy Service (TCS)
12.2024 - Current
  • Create data transfer agreements for vendors (ie, a document which outlines the format a vendor needs to send data back to GSK in)
  • Defining processes for transforming vendor raw data formats to formats suitable for Ingestion into GSK systems if vendor doesn't have capability
  • Work with vendors to arrange test transfers of data
  • Validate format of vendors test transfers versus data transfer agreements using applicable tools
  • Lead ePRO/eCOA setup activities
  • Ensure ePRO/eCOA is built to protocol and study team requirements
  • Lead GSK study teams through User Acceptance Testing processes
  • Inputting into relevant vendor study documents
  • Leads discussions with vendors/study teams during set up around external data acquisition activities

Study Data Manager

Tata Consultancy Service (TCS)
03.2018 - 12.2024
  • To be aware and understand any relevant and applicable trainings around Client SOP and data standard.
  • To perform Data review and discrepancy management as agreed with Sponsor to meet data quality requirements.
  • To coordinate with programming team as appropriate regarding any database or for programming changes need throughout the study period.
  • To address and action data issues highlighted by study team as and when required.
  • To create and distribute data management metrics/listings and reports at an agreed frequency with study LDM.
  • To conduct regular scheduled study meeting with study LDM and to ensure timely documentation of appropriate decisions.
  • Perform YTL/BTL, QMR, SAS Checks Review, Vendor Reconciliation, per protocol update eCRF Completion Guideline.
  • Update vendor Issue log, addition of new checks as per Protocol, perform UAT , take appropriate action for Protocol Deviation in PDMS.
  • Perform Post Database Release (DBR) activities & Pre-Database Freeze (DBF) activities as required based on discussion/agreement with study LDM to ensure quality data delivery.
  • To maintain in-stream archival of relevant study documents in the eTMF system.

Team Lead

Tata Consultancy Service (TCS)
04.2014 - 02.2018
  • To deliver relevant training to the team as per the requirement of the project.
  • To coordinate the workload, prioritize and manage staff as per the workload on a project.
  • Ensure completion of training & project plans.
  • Provide site level support across the teams.
  • To ensure that the timelines of all the deliverables are met, keeping quality as a priority.
  • Motivate the team, to deliver quality work and believe in team spirit.
  • To communicate with the team member’s and resolve or escalate queries.
  • To address any issues of the staff or management.
  • Attend regular teleconference with the internal management and communicate, address any related issues or concerns.
  • To be prepared for audits and prepare the team members for it.
  • Leave Management (Though Final Approval would be done by Operation Manager) -Resignations/Absconder communication to Operation Manager.
  • Timely Metrics capture. Mentoring TM and Updating Organization Structure (in case of any Change).

InForm Study Archivist

Tata Consultancy Service (TCS)
05.2012 - 02.2018
  • Raise request from Oracle Extranet.
  • Removing Live Trail from Server.
  • All InForm Study close out activities and delivery of an error free quality database in accordance with the Document management project plan and regulatory standards.
  • Requesting for study CRFs in PDF format using extranet system.
  • Performing QC of total site CRF’s data & Checking the required data in the CRF’s.
  • Tracking the Receipt of Acceptance Forms from the Investigator & sending the reminder if Acceptance forms are not received within the given time from investigators.
  • Posting the study information on the client shared area and raising the requests to archive the same. Archiving the Electronic Data.(PIER,Veeva).
  • Follow up with Investigator, Monitors & study contact.
  • Request for creating MUL for study.
  • Follow up with Data Manager/study Manager for Removing Live Trail from Server.

Clinical Research Coordinator

Aditya Jyot Eye Hospital
03.2012 - 05.2012

Data Manager & Clinical Research Coordinator

P.D.Hinduja Hospital & MRC
04.2010 - 01.2012
  • Collect Patient data & short listing of patients.
  • Enrollment of study subjects with inclusion and exclusion criteria.
  • Help the Investigator in Inform consent process - Patient Screening & recruitment.
  • Completing CRF entry (OCRDC, Medidata, Epi Info, IVRS, IWRS )
  • Verify the accuracy & validity of data entered in database.
  • Investigational product accountability & dispensing at the site
  • Interacting with IEC / Monitor, IEC update (Submission, Notification, Approval)
  • Maintain & Update Source document, SMF - Keeping the Investigator informed about trial.
  • Management of Lab samples, Courier & follow-ups of Lab report.
  • Help out during Monitoring & Close-out of Project.

Education

PG Diploma in Clinical Research - Clinical Research & Clinical Data Management

CREMA
Mumbai, MH
08.2009

Bachelor of Science - Chemistry

Maharshi Dayanand College
Mumbai, MH
04.2008

Secondary School Certificate -

Sadhana Vidhyalaya
Mumbai, MH
03.2003

Higher Secondary Certificate -

Maharshi Dayanand College
Mumbai, MH
02.2005

Certification

Currently pursuing "Data Analyst" (Tableau,PowerBI,SQL,Python,R-Programming) Course through "ExcelR" in Mumbai

Completed certification for "Six Sigma Green Belt" from "Tata Consultancy Service"

Disclaimer

I do hereby state that the information furnished as above is true to my best knowledge.

Timeline

External Data Acquisition Programmer

Tata Consultancy Service (TCS)
12.2024 - Current

Study Data Manager

Tata Consultancy Service (TCS)
03.2018 - 12.2024

Team Lead

Tata Consultancy Service (TCS)
04.2014 - 02.2018

InForm Study Archivist

Tata Consultancy Service (TCS)
05.2012 - 02.2018

Clinical Research Coordinator

Aditya Jyot Eye Hospital
03.2012 - 05.2012

Data Manager & Clinical Research Coordinator

P.D.Hinduja Hospital & MRC
04.2010 - 01.2012

PG Diploma in Clinical Research - Clinical Research & Clinical Data Management

CREMA

Bachelor of Science - Chemistry

Maharshi Dayanand College

Secondary School Certificate -

Sadhana Vidhyalaya

Higher Secondary Certificate -

Maharshi Dayanand College
Swapnali Sagar Sutar