Partha Mukherjee

Experience

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  Accenture

  Sept 2007 - Apr 2011

  Clinical Data Management Specialist

  Provide inputs to ensure consistency and accuracy of Protocols, Study documentation including Data Validation manual, Data Handling Plans, Data Transfer Specification & eCRF for assigned trials. Coordinate with Coders, Developers, and Third Party Coordinators to ensure that the project timelines and deliverable are met consistently.Coordinate with CRAs for timely resolution of queries.Coordinate with the Database Programmers and Shared service activity leads to ensure timely completion of activities and no backlog accumulated.Performing independent review of data management deliverables following documented guidelines and also review data listings for consistency and accuracy of data.Assist and guide team members in study conduct and close out activities like query management and locking activities.Ensure compliance to applicable project SWPs and applicable SOPsEnsure audit readiness and participate as required.Mentoring new joiners’. Weniger anzeigen

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  Cognizant Technology Solutions

  Apr 2011 - Apr 2013

  Clinical Data Associate

  Create and maintain Trial specific documents.Act as the point of contact for The Clinical Trial Team in relation to all data management deliverables, issues and questions from trial teams and be responsible for resolutions.Perform trial start up activities, including testing and UAT of edit check specifications for assigned trials.Coordinate with Coders, Developers, and Third Party Coordinators to ensure that the project timelines and deliverable are met consistently.Coordinate with CRAs for timely resolution of queries.Coordinate with the Database Programmers and Shared service activity leads to ensure timely completion of activities and no backlog accumulated.Performing independent review of data management deliverables following documented guidelines and also review data listings for consistency and accuracy of data.Assist and guide team members in study conduct and close out activities like query management and locking activities.Track study specific metrics and project forecasting and trends, as applicable.Archive all necessary documents in study folder for audit purposes as per the timelines according to quality and security requirements.Ensure compliance to applicable project SWPs and applicable SOPsFacilitate cross functional team meetings both internally and externally as needed.Mentoring new joiners’. Weniger anzeigen

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  Novartis

  Jul 2013 - Apr 2016

  Clinical Data Manager

   Create and maintain Trial specific documents. Act as the point of contact for The Clinical Trial Team in relation to all data management deliverables, issues and questions from trial teams and be responsible for resolutions. Actively Participate in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided. Provide inputs to ensure consistency and accuracy of Protocols, Study documentation including Data Validation manual, Data Handling Plans, Data Transfer Specification & eCRF for assigned trials.  Identify the need of new standards and coordinate with Clinical Data Scientist. Perform trial start up activities, including testing and UAT of edit check specifications for assigned trials. Coordinate with Coders, Developers, and Third Party Coordinators to ensure that the project timelines and deliverable are met consistently. Coordinate with CRAs for timely resolution of queries. Coordinate with the Database Programmers and Shared service activity leads to ensure timely completion of activities and no backlog accumulated. Performing independent review of data management deliverables following documented guidelines and also review data listings for consistency and accuracy of data. Assist and guide team members in study conduct and close out activities like query management and locking activities. Track study specific metrics and project forecasting and trends, as applicable. Archive all necessary documents in study folder for audit purposes as per the timelines according to quality and security requirements. Ensure compliance to applicable project SWPs and applicable SOPs Support and provide leadership for data management staff for allocated trials. Declare database go-live/ database lock. Facilitate cross functional team meetings both internally and externally as needed. Ensure audit readiness and participate as required. Mentoring new joiners’. Weniger anzeigen

• 

  IQVIA

  Apr 2016 - Jan 2018

  • Medidata RAVE Certified Study Builder and serving as Technical designer for multiple RAVE studies.* Account Manager and Global Librarian for a world renowned bio pharmaceutical company.* Create the Architect Loader Spreadsheet based on protocol and sponsor specifications.* Write edit specifications for the study* Create and maintain system/Core configuration documents- Home page, System Settings, Rights and Roles documents.• Manage project timelines, quality issues, resources, SOW (scope of work) / budget.• Manage a focussed team or a best practice team.• Provide justification for customer negotiations.• May serve as Project Manager for single service data management projects.• Manage comprehensive data management tasks pertaining to the Data Management Plan.• Manage comprehensive quality control procedures.• Provide data management expertise and data coordination process improvement to CDM management.• Interviewing experienced candidates for hiring as per company needs; both via Webex as well as in walk-in interviews.• Mentor other team members and Lead Data Managers in training and developing data management expertise.• Manage the development and implementation of new technology/tool.• Present at professional conferences and/or publish articles in professional journals.• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. Weniger anzeigen • Medidata RAVE Certified Study Builder and serving as Technical designer for multiple RAVE/Inform studies:* Create the Annotated Study book based on protocol and sponsor specifications* Write edit specifications for the study* Create system configuration documents- Home page, System Settings, Rights and Roles* Present the Annotated Study book and Edit specifications document to the internal team• If required, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team.• Manage project timelines, quality issues, resources, SOW (scope of work) / budget.• Manage a focussed team or a best practice team.• Provide justification for customer negotiations.• May serve as Project Manager for single service data management projects.• Manage comprehensive data management tasks pertaining to the Data Management Plan.• Manage comprehensive quality control procedures.• Provide data management expertise and data coordination process improvement to CDM management.• Interviewing experienced candidates for fresh hiring as per company needs outside current location, both via Webex as well as in walk-in interviews.• Mentor other team members and Lead Data Managers in training and developing data management expertise.• Manage the development and implementation of new technology/tool.• Present at professional conferences and/or publish articles in professional journals.• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. Weniger anzeigen

  • Associate Manager

    Jan 2017 - Jan 2018

  • Assistant Manager

    Apr 2016 - Nov 2017
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  The Emmes Corporation

  Jan 2018 - Sept 2019

  Manager - Data Management

  Manager in Data Management

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  Labcorp

  Nov 2019 - Jan 2023

  *Responsible for configuration and implementation of EDC services within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data.*Responsible to act as a technical liaison with project team members, clients and Data Managers to drive the technical aspects of project delivery.*Assisting in development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, and Oracle Inform, or other proprietary software, including proactive prevention strategies.*Assisting in development of global technical services competency model and also develop training programs to ensure staff is trained in study build, change control and/or CRF Design.*Providing consultation on the area of database design and development with data managers and providing expert technical guidance to project teams, external clients and internal clients within a global setting.*Providing feedback to management on the development potential of staff to assist in staff development and, also participate in the evaluation and validation of new or updates to software. Weniger anzeigen

  • Principal Programmer, CDM and Programming

    Jun 2022 - Jan 2023

  • Lead Programmer

    Nov 2019 - Jun 2022
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  Fortrea

  Jan 2023 - now

  Principal Programmer