Rahul Mukherjee

Experience

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  Cognizant Technology Solutions

  Nov 2007 - Mar 2011

  Data Manager

  • Review and action queries on an ongoing basis and update database on the query resolution.• Perform UAT according to Validation Plan of all applicable Data Management systems.• Perform ongoing and final consistency checks, review protocol deviation handling document and data listing to ensure that all data have been handled appropriately according to the DMP and CRF Review Manual.• Produce list of protocol deviations if any using standard template/ reports.• Perform SAE Reconciliation between the Safety and Clinical study databases with supporting documentation. Show less

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  Novartis

  Apr 2011 - Jul 2012

  Clinical Data Specialist

  • Provide professional DM input on Clinical Trial Team(s). Input to and review of clinical trial database design including User Acceptance Testing (UAT). • Provide input for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes taking an active part in the meeting, providing input in writing the study specific validation checks and necessary reports to ensure high quality and consistent data• Identify errors and inconsistencies and resolve the discrepancies• Review and contribute to preparation of protocols• Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper• Responsible to develop, coach and provide training to Data Management team and also to provide their performance feedback/multirater feedback to Global Project Leads and Global Program Head’s of Oncology team Show less

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  Tata Consultancy Services

  Aug 2012 - May 2015

  • Develop and maintain effective working relationship with Project Manager and client personnel• Provide bidding cost as per synopsis/protocol for preparation of work order/change order• Concurrently manage end-to-end activities for the allocated CDM studies from CRF design to data transfer (after DB lock) by coordinating with teams comprising of DMs and programmers• Responsible to ensure completion of projects within budget/effort constraints and as per agreed timelines; ensure availability of resources throughout the project lifecycle.• Execute performance review and maintain appraisal timelines for the allocated team members• Face internal Quality, IT audits and external audits• Manage day-to-day team activities (e.g. timesheets, dashboards, training files etc)• Train CRAs, investigators and other study/site personnel on DM functions at the investigator/kickoff meeting• Responsible for the work allocation to the team• Participate in recruitment and selection of team members Show less • Review Clinical study protocol and design Case Report Forms (CRF) to facilitate data collection and entry that meet statistical analysis requirements.• Support project management and process planning• To manage the data management metrics and proactively identifies quality and timeline issues. • Handle study start-up and conduct activities including creation of eCRFs, DMP, eCRF Specification, eCRF Completion guidelines, Visit Matrix, Edit checks Document, study specific documents and overseeing database design, procedure testing, discrepancy management, third party vendor data management and for assigned CDM projects.• To escalate issues that would impact the study delivery, to the appropriate level to ensure resolution and implements any corrective action plan• To monitor discrepancy management to ensure appropriate quality of data by regular checks during study start-up and conduct• Provide regular status reports to Project Manager Show less

  • Assistant Manager

    Apr 2013 - May 2015

  • Team Lead

    Aug 2012 - Mar 2013
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  IQVIA

  Jun 2015 - Oct 2018

  * Manage a team of professional Data Management staff a size of 8 team members.* Directly responsible for utilization of staff.* Provide review and guidance for production of Data Management documentation or deliverables that are produced by the Data Management Function.* Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.* Participate in the implementation of new processes and technology.* Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.* Mentor staff members to develop Data Management process and system expertise. Show less • Develop and maintain effective working relationship with Project Manager and client personnel• Served as Data Team Lead (DTL) on multiple global studies.• Provide leadership to Data Management (DM) team.• Manage data management customer relationship for data management project team including active participation in data management customer negotiation on timeline, budgetary and other issues.• Manage team of Data Operation Coordinators, Reviewers and Programmers involved in Project• Manage delivery of projects through full data management process life cycle.• Provide end to end support to various stakeholders involved in projects • Provide full support to all data management activities.• Perform comprehensive quality control procedures.• Solves issues through the global issue escalation/communication plan.• Consult with Standards Group for process issues; communicate ideas for process improvement.• Assist in developing and implementing new technology.• Understand and comply with core operating procedures and working instructions. Show less

  • Associate Manager

    Jan 2018 - Oct 2018

  • Assistant Manager

    Jun 2015 - Dec 2017
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  Accenture

  Oct 2018 - now

  * Primary interface with client leadership and accountable for overall operation and senior project management oversight of all deliverables of PDM team.* Effectively leads team of PDMs assigned to the protocol, demonstrating strong interpersonal and people management skills.* Serves as primary operation contact for Study/Functional level.* Exhibits strong project management and organizational skills to monitor study progress and manages Line management responsibilities of reporting PDMs.* Own proven team building skills and ability to foster partnerships across projects. Communicate effectively to influence, inform and guide others.* Follow appropriate escalations pathway to inform internal as well as external stakeholders of problems and potential solutions.* Ensure project delivery to client within the set timelines and per quality expectations for the process. Show less * Serves as primary operational contact for Study/Functional level.* Accountable for completion of all database lock activities of the reporting PDMs to the standards expected* Contribute to the establishment and/or development of best practices and ensure best practices are shared to key stakeholders to support consistency within a program.* Stakeholder management with the ability to multi-task and manage high performance demands.* Interviewing and hiring new employee* Provide feedback to the team or quality, productivity, efficiency improvement; and ensure necessary corrective measures are taken.* Work with other cross functional Accenture Team Leads for effective and timely resource allocation.* Exhibits strong knowledge in Oncology clinical trials and provide mentoring support to assist PDMs. Accountable for data management start-up, lock or database activities. Oversee all studies assigned to reporting PDMs and suggest resolutions for the issue highlighted by PDM independently. Show less

  • General Manager (CDM)

    Dec 2021 - now

  • Senior Manager

    Oct 2018 - Nov 2021