Sudha Parimala, CCDM

Experience

• 

  Infoscript Services Private Limited

  Oct 2000 - Mar 2005

  Medical Transcriptionist

  A Medical Language Specialist - Conversion of voice file to electronic data. Transcribing medical records, dictated by doctors, nurses, and physician assistants, including history and physical reports, progress reports, clinic notes, office notes, operative reports, consultation notes, discharge summaries, letters, psychiatric evaluations, laboratory reports, x-ray reports and pathology reports.

• 

  Acusis

  Jun 2005 - Jul 2007

  Home-based medical transciptionist
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  Ecron Acunova

  Dec 2007 - Feb 2014

  • Ensure to oversee all data management activities for CDM projects.• Deliver the project with all milestones completed in time compliant with scope of work, sponsor’s specifications/process and SOPs.• Understand and comply with all the SOPs.• Development of data management team by providing trainings & assessments.• Ensure team is trained appropriately for the project and understand the protocol requirement/sponsor’s requirement/SOW.• Responsible for conducting project wise status update meeting and ensure the project delivery as per work plan/project plan.• Review the work/documents and take decision on complete end-to-end activity of data management.• Provide inputs for process optimization in alignment with the SOW and sponsor’s requirement.• Resource management which includes risk management/transition management/resource allocation.• Periodic assessment of goals and objectives set for the different role including self.• Provide feedback to clinical data coordinators for quality and efficiency improvement.• Provide peer feedback for quality and efficiency improvement.• Responsible for handling the sponsor audit/provide clarification/CAPA• Responsible for customer focus, satisfaction and feedback.• Tracks projects and metrics.• Provide inputs on development and revision of CDM SOPs.• Provide feedback on development and revision of CDM Process Documents.• Motivating and encouraging team and provide support.• Coordinates with clients and recognize out-of-scope activities.• Organize mentoring for new employees as and when required.• Participate and attend in various inter-departmental workshops as a means of process improvement and knowledge share. Show less • Review and deliver required data/documents in compliant with SOW/sponsor’s specifications/process and SOPs and adhere to the timelines and project specific instructions set by PDM.• To participate and give input for process optimization in alignment with the SOW and sponsor’s requirement.• Periodic assessment of goals and objectives set for the role.• Understanding the protocol and scope of work and provide input for all the study set up activities.• Providing input for CRF design and database design.• CRF annotation and database designing• Creation of the DMP including validation check document.• Performing validation of database/UAT and preparing related documents.• Performing discrepancy management as per DMP.o Cleaning the CRF data.o Non-CRF data reconciliation.o SAE reconciliation.• Review for DMSF updation.• Carry out QC as per QC plan and create relevant document.• Generation of status report periodically (for internal requirement/for sponsor requirement) as requested by PDM.• Request for interdepartmental meeting/delivery team meeting regarding project related issues/requirements/escalations.• Participating and attending in various inter-departmental workshops as a means of process improvement and knowledge share.• Timely updation of Work Plan to have an update on CTQs and goal & objectives.• Coding of Adverse Events & Medical History terms using MedDRA and coding of Concomitant Medications using WHO-DD.• Part of PQ team for paper based trials done on Oracle Clinical 4.5.3.• Part of narrative writing team for a multinational client. Show less • Deliver required data/documents in compliant with SOW/sponsor’s specifications/process and SOPs and adhere to the timelines and project specific instructions set by PDM.• Understanding the protocol and scope of work and provide input for all the study set up activities.• CRF designing using Adobe InDesign.• Creation of the DMP including validation check document.• Preparation of dummy data for database screen validation.• QC of raw datasets.• Preparation of clean and dirty data and validation of edit checks.• Performing discrepancy management as per DMP.o Cleaning the CRF data.o Non-CRF data reconciliation.o SAE reconciliation.• Review for DMSF updation.• Carry out QC as per QC plan and create relevant document.• Participating and attending in various inter-departmental workshops as a means of process improvement and knowledge share. Show less

  • Associate Project Data Manager

    Apr 2013 - Feb 2014

  • Senior Clinical Data Coordinator and Medical Coder

    May 2011 - Apr 2013

  • Clinical Data Coordinator

    May 2008 - Apr 2011

  • Clinical Data Associate

    Dec 2007 - Apr 2008
• 

  Quintiles Research India Pvt Ltd.,

  Feb 2014 - Jun 2018

  • Associate Data Team Lead

    Apr 2016 - Jun 2018

  • Sr. Clinical Data Coordinator

    Feb 2014 - Mar 2016
• 

  IQVIA

  Jul 2018 - now

  Data Team Lead
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  Tata Consultancy Services

  Oct 2021 - now

  Manager Data Management