Parexel Senior Clinical Data Analyst

2 weeks ago


Bengaluru, Karnataka, India Parexel Full time
Job Summary:

The role of Senior Clinical Data Analyst involves independently performing and/or coordinating all clinical data validation activities on assigned projects. Responsibilities include providing technical expertise and operational leadership regarding data management operational activities, processes, and documents.

Key Responsibilities:

  • Lead and/or coordinate data validation activities during conduct and database lock.
  • Highlight issues/risks to delivery and support mitigations as part of the Risk Management Plan.
  • Perform and/or support the setup of data management documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
  • Lead/perform user acceptance testing on clinical database setups.
  • Track and review CRFs, support data entry where required.
  • Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
  • Perform/Lead functional QC activities on databases and/or patient data.
  • Act as a subject matter expert regarding DM operational tasks/tools/processes/systems.

Requirements:

  • Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products.
  • Advanced understanding of data management processes and data validation flow.
  • Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study specific procedures.
  • Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system.
  • Experience in clinical research industry.

Location: Bengaluru/Hyderabad/Mumbai/Mohali



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