Rakesh Nikose

Experience

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  Cognizant

  Jul 2007 - Jun 2011

  Team Lead Manager

  Leading Data Acquisition team which involved extraction and managing third party data (vendor management), creating agreements, and ensuring standards are followed, leading SAS programming and validation team, to carry out validation activities like validation of IVRS and ePRO system and devicesGathered project information and planned for validation deliverables meeting customer requirements appropriately. Responsible for providing inputs and reviewing all validation related deliverables, setting up expectation and priorities on each project activitiesKey Responsibilities: Served as primary point of contact for customer on data management deliverable of assigned trial. Developed project plan on study start up activities and well negotiated with all the stakeholders to finalize study timelines. During startup of the trial, creation of key documents was major responsibility. e.g. contact list, training list, communication plan, standard operating procedure linked to project instruction, trial data flow diagram, UAT process and documentation, Data cleaning Plan, Quality control plan and their finalization. Responsible for data cleaning of third-party vendors, including preparation of transfer agreement development and testing of vendor data integration into the trial database. Established strong communications with Data Operations team, functional leads, project managers and all other stakeholders Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW Served as Subject Matter Expert (SME) on IXRS design built and proposed changes on database structure Show less

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  Tata Consultancy Services

  Jun 2011 - Dec 2013

  Project Manager – Data Management & Clinical Programming

  Responsible for managing operations & delivery of Clinical Data Management activity for leading pharmaceutical client in Clinical and SAS ProgrammingKey Responsibilities: Accountable for metrics delivery, resourcing, revenue generation in terms of new business. Successfully transitioned 18 studies from Oracle Clinical Platform to Rave by establishing all development project scopes, schedules, resource plan and budgets Responsible for ensuring consistency of protocol with CRF built, clinical databases built for all trials. Developed and delivered face to face CDM presentations for Project Kick-off Meetings, CRA workshops, and Validation Plans as appropriate Monitor clinical data quality and progress of trials with TCS standards; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data. Presented Quarterly metrics, reviewing KPIs and reviewing invoices on task performed Track best, worst and most likely case scenario by creating FMEA (Failure Mode Effective Analysis) to ensure that mitigations plans are in place Show less

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  Accenture

  Dec 2013 - Apr 2015

  Head of Business Excellence

  Responsible for driving Lean Six Sigma and continuous improvement projects for all PV and CDM domain. Reviewing project processes and key deliverables, as part of the organization's quality program and coach projects on resolving the assessment gaps for greater delivery excellence.Driving analytics projects in CDM resulting in revenue generation of $ 600 K. Developed Reconciliation tool for CDM clients by automating the process with net saving.Key Responsibilities: Served as Business Excellence Lead and ensured successful completion of project launch and delivery of all data management activity Improving TAT, productivity and challenges w.r.t process, people and technology by driving Lean Six Sigma techniques Monitor project progress, status reports, metrics, monthly study KPI, study budget burn and share status to management Plan, manage and get right resource for assigned projects by Lean methodologies Supported sponsor and third party by sharing process related response and CAPA from QA Show less

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  IQVIA India

  Apr 2015 - May 2023

  Sr. Manager, Clinical Data Management

  Project Manager/Project Lead for a major study or a series/group of studiesProvide project management expertise working with customer data managers, manage continuous process improvements, issue escalation, workload projections.Establish and maintain strong, long-term relationships with key executive level decision-makers developing deep knowledge of stakeholder needs and ensuring delivery of a service level in line with strategic goals.Manage SOW/budget:Review financial reports on a monthly basis and participate in project reviews as requested. Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.May be Project Manager/Project Lead for a major study or a series/group of studies Provide project management expertise working with customer data managers, manage continuous process improvements, issue escalation, workload projections. Establish and maintain strong, long-term relationships with key executive level decision-makers developing deep knowledge of stakeholder needs and ensuring delivery of a service level in line with strategic goals. Determine strategic goals and objectives for the group and ensure operational alignment with senior management priorities.Direct and lead the clinical data management function globally and use exceptional planning and organization skills to manage multiple projectsLead and direct functional strategic initiatives and partner with key stakeholders to develop implementation Show less

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  IQVIA

  May 2023 - now

  Senior Global Project Consultant, Clinical Data Management - IQVIA

  To manage all DM consulting projects (larger and/or program of studies) from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions. To ensure on-time and on-budget delivery contributing to new business development.Collaborates with the project teams- both internal and external on overall data management strategy for the program and/or projects, assuring overall quality and efficiencyRepresent DM at internal and sponsor project team meetings to discuss PHS, going through timelines and status of deliverables, like KPIs and metricsRisks: Going through risks pertaining to TPV, missing / ageing queries, milestone achievement during set up (go-live), conduct (IAs) and DBLDevelops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and SponsorAssumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resourceDiscusses roadblocks to DM deliverables and potential strategies for overcoming with project team Develop and implement continuous improvement processes to ensure the operational environment is functioning at maximum efficiency and automationDevelops, Maintains and Archives DM Project Documentation including:• Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required• Data review listing specifications• Database Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications• Database lock documentationRepresents Data Management at Bid Defense Meetings (BDM)• Prepares project-specific slide presentation from DM template functional slides• Participates in BDM preparation meetings including discussing overall DM strategy• Presents DM slides at BDM and constructively participates in discussion Show less