SHILPI DAS

Experience

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  Clinotek India

  Aug 2010 - Nov 2010

  Course Co-ordinator
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  D2L Pharma Research Solutions Private Limited

  Dec 2010 - Apr 2012

  Clinical Trial Assistant

  •Preparing feasibility databases for sites involved in various therapeutic areas.•Conducting feasibilities for recognizing potential Principal Investigators and Sites for studies. •Preparation of study documents according to site specific Ethics Committee Standard Operating Procedures for submitting to Ethics Committee Approval.•Tracking of the documents submitted to Ethics Committee and review of the approval documents.•Prepare, maintain and update the in-house trial related files according to Standard Operating Procedures, Indian applicable regulations and ICH GCP.•Organizing, managing and co-ordinating for Investigators’ Meeting.•Interacting, co-ordinating and managing all site’s Clinical Research Co-ordinators for completion of study related documents, filing them in Site Master File (SMF) and getting the daily updates of the status of the study.•Periodically organizing Site Initiation, Monitoring and Close-out Visits for CRA.•Independently perform Interim Monitoring Visit to assess the progress of the study completion and verification of the study data and patient records, accountability of the trial materials, compliance with study procedures and GCP.•Design and maintain project status trackers for easy operation of the study.•Designing and updating balance sheets for biosamples for all the sites involved in the study.•Resolution of Case Report Form and Data Clarification Form queries and timely providing them to data management team.•Organize, process and track the investigator payment as per the agreement.•Assist project managers and senior CRA with the day to day running of the clinical studies.•Maintain regular and effective communication with project team and clients to assure trial activities are coordinated with in the project timelines.•Assisting with management of study drug, biosample supply/ shipment and accountability. Show less

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  Cognizant

  Jul 2012 - Jan 2014

  Junior Data Analyst

  •Handled Phase I, II & III oncology and infection studies with complex protocol•Study Set-up activities: For RAVE in Oncology and Infection areas, Module assessment (selection of various eCRF from the central repository), creation of Visit Matrix, annotated e-CRF Spec (Unique) and Expanded form, Module specific and general e-CRF Instructions/ Data Entry Guidelines, e-CRF Review Manual for monitors, Data Validation Spec, Creation of Data Management Plan (DMP) documents.•Performing User Acceptance Testing (UAT) for e-CRF forms, validation checks, SAE E-mail alert testing, Liver assessment form (PHL E-mail alert) testing, coordinating with various teams involved for process, IVRS/IWRS set up, Local Lab reference set up, relevant Documentation and other Go-Live activities.•Study Conduct activities: Review data and discrepancies, performing manual checks, raising and closing queries and following up the study team regarding the issues with the queries and the resolution provided to them depending upon the study, for Oncology studies performing RECIST 1.1 Guideline Checks, •Data Transfer Specification (DTS) for Third Party Vendor (TPV) data import, TPV data reconciliation like ECG, PK, Genetics, Lab etc. against EDC database, Serious Adverse Event (SAE) Reconciliation.•Attending TC with the study team regarding the issues and the update periodically, preparing Minutes Of Meeting (MOM) and Issue Log.•Review of protocol deviations and reporting, providing reports for the discrepancies. Also performed assigned Database lock activities and documentation. •Involved in Study Migration activities like the creation of Change Request including the details of the change in the database, validation checks, data output, impact analysis, performing UAT, documentation of Change Closure Form etc. •Ensuring regulatory guidelines met, participating in knowledge sharing sessions, providing documents for filling in the Trial Master File (TMF). Show less

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  IQVIA

  Jan 2014 - May 2020

  • Serving as a Data Team Lead (DTL) on global clinical trials with more than 10 operational staffs.• Provided leadership to whole CDM operational team involved.• Managed customer relationship for CDM study team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.• Managed and provided budget overview of CDM and negotiations.• Ensured compliance to organizational budget and quality standards• Ensured team is trained appropriately for the project and understand the protocol requirement/sponsor’s requirement/SOW.• Conducted study wise status update meetings with operational team for project deliverable as per project plan, and tracked metrics on a regular basis or any adhoc-requirements.• Managed project timelines, deliverable and quality issues for the study efficiently.• Resource management which includes risk management/transition management/resource allocation for the project.• Ownership for customer focus, satisfaction and feedback managed efficiently. Show less • Served as a Data Team Lead (DTL) on global clinical trials with more than 10 operational staffs.• Provided leadership to whole CDM operational team involved.• Managed customer relationship for CDM study team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.• Managed and provided budget overview of CDM and negotiations.• Ensured compliance to organizational budget and quality standards• Ensured team is trained appropriately for the project and understand the protocol requirement/sponsor’s requirement/SOW.• Conducted study wise status update meetings with operational team for project deliverable as per project plan, and tracked metrics on a regular basis or any adhoc-requirements.• Managed project timelines, deliverable and quality issues for the study efficiently.• Resource management which includes risk management/transition management/resource allocation for the project.• Ownership for customer focus, satisfaction and feedback managed efficiently. Show less • Served as a Data Operations Coordinator (DOC) for global oncology and arthritis studies with fewer than 10 operations staff and in the role of back-up to a Data Team Lead for Inform 4.6 and 5.5 studies.• Managed delivery of projects through full data management study life-cycle (with minimal guidance).• With guidance from DTL & Manager, managed project timelines and quality, determine resource needs, identify out of scope work.• Serving as back-up for Data Team Lead (with guidance).• Performing comprehensive data management tasks for study conduct including data review, writing, discrepancy management (Non-eCRF data reconciliation and SAE reconciliation) and resolving data clarifications. • Performing comprehensive quality control procedures as per QC plan and relevant documentation, DMSF updating.• Performing database set-up tasks UAT/validation of database, edit-checks, reports, data transfer, creation of DMP documents etc. • Solved issues through using the global issue escalation/communication plan.• Understand and comply with core operating procedures and working instructions.• Met objectives as assigned, received continues rating of exceed expections since last 4 years.• Develop and maintain good communications and working relationships with CDM team.• Interact with CDM team members to negotiate timelines and responsibilities.• Training and mentoring sessions for newly joined and experienced team members as required.• SME role for Coding tool set-up validation. Show less • Served as a Data Operations Coordinator (DOC) for global oncology and arthritis studies with 2-5 operations staff and in the role of back-up to a Data Team Lead for Inform 4.6 and 5.5 studies.• Managed delivery of projects through full data management study life-cycle (with minimal guidance).• With guidance from DTL & Manager, managed project timelines and quality, determine resource needs, identify out of scope work.• Serving as back-up for Data Team Lead (with guidance).• Performing comprehensive data management tasks for study conduct including data review, writing, discrepancy management (Non-eCRF data reconciliation and SAE reconciliation) and resolving data clarifications. • Performing comprehensive quality control procedures as per QC plan and relevant documentation, DMSF updating.• Performing database set-up tasks UAT/validation of database, edit-checks, reports, data transfer, creation of DMP documents etc. • Solved issues through using the global issue escalation/communication plan.• Understand and comply with core operating procedures and working instructions.• Met objectives as assigned, received continues rating of exceed expectations since last 2 years.• Develop and maintain good communications and working relationships with CDM team.• Training sessions for newly joined members as required. Show less

  • Associate Data Team Lead

    Mar 2019 - May 2020

  • Senior Clinical Data Co-ordinator (Performing DTL)

    Jul 2018 - Mar 2019

  • Senior Clinical Data Co-ordinator

    Apr 2016 - Jun 2018

  • Clinical Data Coordinator

    Jan 2014 - Mar 2016
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  Teva Pharmaceuticals

  May 2020 - Jun 2021

  Clinical data management Professional II - Lead Data Manager

  • Serving as the Lead Data Manager for global studies with managing all stakeholders involved.• Understanding study protocol, preparation and review of CRF design, Time and Event schedule, Data Validation Plan (DVS), manual listings as applicable, eCRF Completion Guidelines, Data Management Plan (DMP), SAE reconciliation plan, Medical Coding and review plan, Vendor data agreement, Data transfer specification and vendor data cleaning/reconciliation plan.• Performing screen review and UAT as applicable.• Managing all data management activities for conduct studies single handedly like query management, SAE reconciliation, vendor data reconciliation, coding review.• Updating study metrics for the DM status as per the decided frequency or as and when required for study update.• Performing and managing Database lock activities per the timelines and dataset review before final data delivery.• Effective and complete documentation and to be audit ready at all time of the study duration.• Managing study CRF submit process, providing and tracking updated CRF CDs to site.• Review work of team members to maintain the quality of the deliverables. • Prioritizing and plan the tasks efficiently to meet the project deliverables in time. Show less

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  Tata Consultancy Services

  Jun 2021 - May 2023

  Manager

  • Overall in-charge of all DM activities for a study including set-up, conduct and close out as a single POC for all DM needs• Primary point of contact for CDM works as liaison for programming, data acquisition and non-eCRF data cleaning teams• Monitoring and evaluating overall study progress and study health, identifying potential risks/challenges• Conducting regular team meetings for study update and provide guidance on study related issues to Client and internal higher management team• Monitoring, maintaining and reporting KPI/SLAs/metrics on the study• Ensuring adequate resourcing for the study lifecycle and discussing requirement with management team and finalizing resources• Keeping records of all regular DM activities for ensuring smooth flow of the study, discussing priorities and study targets with all stakeholders involved in the study• Providing support and training on CDM activities to newly joined team members on a floor level • Building effective DM practices and process for enhancing domain expertise• Ensuring team members deliver high quality work and follow all effective and required DM processes, SOP and documentation requirement for training/assessment• Responsible for ongoing monitoring and development of study team at a functional level• Provide assistance in recruitment and selection of team members from a domain technical evaluation perspective Show less

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  ICON Strategic Solutions

  May 2023 - now

  Group Leader- Clinical Data Management