Ajith Mohan

Experience

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  E4e Business Solutions Pvt Ltd

  Jun 2006 - Jan 2009

  Technical Support Executive

  We were supporting Symantec - Norton Products Technical Support for APAC region.

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  Lotus Clinical Research Academy

  Jan 2009 - Apr 2010

  Clinical Data Management - Executive

  I was part of setting up Clinical Data Management team. I was part of creating SOPs, performing end to end activities, which included Start -up, Conduct and Closeout for Oracle Clinical studies.

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  IQVIA

  May 2010 - Oct 2021

  Provide Line Management support for 20 team members across different TA. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.Provide expertise on Clinical Data Management, escalation support for issue resolution and contingency planning.Lead multiple internal department initiatives that has helped in streamlining and improving metrics around Operations.Operational Lead for Subject Matter Expert Team. Operational Lead for Internal – Quality Review Process Show less Provide Line Management support for 15 team members. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Mentor DM staff across multiple project teams. Ensures that staff fulfill their responsibilities in accordance with company policies, Standard Operating Procedures (SOP), International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.Manage delivery of projects through full data management study life-cycle. Maintain good communications and working relationships with internal and external stakeholder. Participated in Operational Review meeting with Sponsors.Operational Lead for Subject Matter Expert Team. Operational Lead for Internal – Quality Review Process Show less Manage a team of 5-10 people. Support both Project Management and People Management. Good people management skills including mentoring, coaching, interviewing, providing feedback and recognition Managed staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee related issues and resolving problems. Manage project timelines, resource projections; identify out of scope work, manage KPI/ SLAs and quality control for the study. Show less Perform Data validation (Reviewing, cleaning and processing) of Phase I to Phase IV clinical data on RAVE platform which includes and not limited to Query management process, Listing review, Eye icon review. To perform Database User Acceptance Testing, Edit Checks UAT (creating the test conditions and validating the edit checks for the study); ensuring that the sites updates the data per CRF completion guidelines. To meet data validation with high quality.Also, additional role as Data Operations Coordinator: Responsible for project management of Phase I to Phase IV EDC studies. To provide the clients with monthly metrics update, conduct basic quality control procedures, ensuring that the data management tasks are completed within the turnaround time and coordinating with the Data Entry and Programming teams for the smooth functioning of the study. Show less Joined IQVIA as Associate Clinical Data Coordinator. Perform Data validation (Reviewing, cleaning and processing) of Phase I to Phase IV clinical data on RAVE platform which includes and not limited to Query management process, Listing review, Eye icon review. To perform Database User Acceptance Testing, Edit Checks UAT (creating the test conditions and validating the edit checks for the study); ensuring that the sites updates the data per CRF completion guidelines. To meet data validation with high quality. Show less

  • Manager, Clinical Data Management

    Jun 2019 - Oct 2021

  • Associate Manager, Clinical Data Management

    Apr 2016 - May 2019

  • Assistant Manager, Clinical Data Management

    Apr 2014 - Apr 2016

  • Senior Clinical Data Coordinator

    Apr 2012 - Apr 2014

  • Clinical Data Coordinator

    Apr 2011 - Apr 2012

  • Associate Clinical Data Management

    May 2010 - Apr 2011
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  ICON plc

  Oct 2021 - now

  As a Senior Manager in Clinical Data Science, I lead and mentor high-performing teams to ensure the integrity, quality, and timely delivery of clinical trial data. I oversee the planning, execution, and monitoring of data management activities, ensuring compliance with regulatory standards such as GCP, FDA, and ICH guidelines. By collaborating with cross-functional teams, I drive the development and implementation of data management plans and data validation processes for clinical trials. My focus is on maintaining the highest standards of data quality, managing resources, timelines, and budgets, and continuously improving data management processes. With extensive experience in clinical data management, I bring a strategic approach to optimizing processes and driving innovation in operations. Show less Provide Line Management support for ~20 team members across different departments. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Operational Lead for eTMF and Business Project Associates across globally.Operational Lead for Internal – Quality Review Process.Grow eTMF and BPA team to support eTMF filing and Project Management support to LDMs and Account leads. Lead multiple internal department initiatives that has helped in streamlining and improving metrics around Operations.Provide expertise on Clinical Data Management and Risk Based Monitoring studies, escalation support for issue resolution and contingency planning.Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Support in employee appraisal and career growth. Show less

  • Senior Manager

    May 2024 - now

  • Manager, Clinical Data Management

    Oct 2021 - Mar 2025