Nithin Kandy

Experience

• 

  Alembic Pharmaceuticals Limited

  Sept 2002 - Sept 2004

  Marketing Executive

  • Localized sales strategies• In depth knowledge about the product• Sales turnaround• Successful product launches• Competitive Analysis

• 

  Accenture in India

  Jan 2005 - Jan 2008

  Subject Matter Expert

  • Delivering quality clean patients and quality databases • Create end to end process maps (Process flow Chart/ Deployment Flow Chart)• Suggest process improvements• Developed strategies in co-ordination with Team leads and Project Managers so as to meet quality requirements efficiently • Provides support to develop and update guidelines• Perform final database quality checks • Improving validations and guidelines• Utilized various tools to review data for quality issues slipping through the data validation process. Correct quality issues to deliver complete, high quality product to the client• Reviewed data using tools like CDRS, SUDS, E Review reports, SAS reports etc, to identify and resolve quality issues• Supports data validation package design• Identified trends in types of errors and suggests / implements course of actions.• Provided expert comments and feedback on quality initiatives/Process improvements Show less

• 

  Tata Consultancy Services,

  Jan 2008 - Aug 2011

  Team Lead

  • Lead role in coordination of clinical data management for assigned studies• Ensure that the timelines of all the deliverables are met, keeping quality as a priority.• Workload projections and resource management • Provide technical assistance to team members for study issues• Understand and meet client requirement • Handle client escalation , perform root cause analysis and recommend corrective actions • Training and Development• Quality Checks for associates • Project Level contribution• Coordinated and conducted CDM process presentations for various Client Visits• Identified non value added activities , created process flow to identify the waste • Monitor and track SLAs/Metrics on project level• Contributed to Investigators and other project meetings• Extensive contribution in defining baselines and productivity data capture methodology for various activities in data processing• Assisting Project Manager in data analysis for various initiatives Show less

• 

  Novo Nordisk

  Sept 2011 - now

  •Manage the DM team according to the Novo Nordisk way including developing the employees and the team to meet Novo Nordisk business needs.•Trial allocation and execution of data management tasks during start-up, conduct and closure phases for allocated Phase 1 trials.•Ensure deliverables of Paper CRF’s across projects and phases•Manage the unit/ team according to the Novo Nordisk Way to meet the team as well as DM dept. and Novo Nordisk’ business needs.•Align coding with the Global safety Team.•Ensure continuous improvement and quality mindset with focus on compliance•Handling the team of CRF designer, Coders and Phase 1 DM’s•Set targets for the team according to the overall strategies for •Follow up on deliverables ensuring timely, high quality and cost-effective outcome and communicate progress to the manager.•Ensure optimal and flexible use of resources in the team, and timely identification of resource gaps and the consequences, and for identifying possible solutions.•Support recruitment•Be part of planning and making contributions to department meetings, raise relevant issues and inform relevant parties, and contribute to the general information flow within the department.•Provide input to department budget e.g. travel and courses. Show less

  • Director

    Jul 2023 - now

  • Associate Director, Clinical Data Management

    Mar 2023 - Jun 2023

  • Senior Manager, Clinical Data Management

    Aug 2020 - Feb 2023

  • Manager, Regulatory Affairs

    Oct 2017 - Jul 2020

  • Team leader, Associate Manager, Clinical Data Management

    Sept 2011 - Sept 2017