Abdul Basith Senior Clinical Data manager-Novo nordisk -8 years
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Hello, I am Basith. I work in clinical research with strong experience in Clinical Data Management and clinical trial operations, including experience working with Novo Nordisk.
Through my work, I have been involved in managing clinical trial data processes, ensuring data quality and regulatory compliance, developing data management plans, and supporting database lock and submission-ready datasets. I have also worked closely with cross-functional teams to ensure clinical trials run smoothly and data is accurate and reliable.
I enjoy helping students understand how clinical data management works in real clinical trials, beyond just theory. My sessions focus on practical understanding, including topics such as:
Clinical trial data flow
Data management plans and data quality checks
Clinical database processes and database lock
Risk identification and project oversight
Regulatory and quality expectations in clinical trials

If you are a student or early professional interested in clinical research or clinical data management, I would be happy to guide you and share practical insights from real industry experience.
My goal is to make complex clinical research concepts clear, practical, and easy to understand.

Subjects

  • Clinical Research Beginner-Expert

  • Clinical Data Management Beginner-Expert

  • Stakeholder Management Beginner-Expert

Experience

  • Senior clinical trial data manager (Jul, 2021–Jan, 2026) at Novonordisk
    • Oversee end-to-end clinical trial delivery in line with project goals, planning, and assigned activities.
    • Leading data standards initiatives, maintaining compliance, and driving effective project management, all while ensuring the integrity of data and excelling in cross-functional communication.
    • Manage data-related project oversight and ensure compliance with clinical trial standards
    • Identify project risks, facilitate decision-making, and provide management reporting.
    • Guarantee timely availability of clinical data that meets regulatory and quality standards.
    • Ensure data management systems and interfaces are set up and compliant with internal requirements.
    • Develop and execute a comprehensive Data Management Plan for all data management activities.
    • Create a data quality plan for each trial, including data checks and blinding protocols.
    • Maintain clear communication with trial partners and follow up promptly.
    • Utilize data visualization methods for operational decision-making and data review.
    • Conduct database lock activities and maintain ongoing trial documentation for archival.
    • Perform post-database lock activities to ensure data is submission-ready.
    • Resolve major issues with support from Project Data Manager or relevant DM unit Manager
    • Prepare for and participate in audits and inspections.
  • Clinical data analyst (Jan, 2018–Jul, 2021) at Accenture
    • Conduct thorough reviews of Case Report Form data for accuracy and consistency adhering to data standards and guidelines
    • Resolve data discrepancies, serve as the primary contact for data queries, and ensure timely task completion by clinical data managers
    • Utilize J-Review for report generation and manual checks, maintaining data integrity throughout the process
    • Act as the liaison for third-party reconciliation, managing vendor data and SAE-related discrepancies.
    • Monitor query status and perform data cleaning to uphold data quality and governance.
    • Participate in data quality review meeting, contribute to data management training and collaborate effectively in team setting.

Education

  • Msc Microbiology (Jul, 2015–Apr, 2017) from M.S.Ramaiah college of Arts, Scence & Commerce

Fee details

    ﷼70–150/hour (US$19.23–41.21/hour)

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