Clinical Data Analyst II

6 days ago


Bengaluru, Karnataka, India Parexel Full time
Clinical Data Analyst II

About the Role:

We are seeking a highly skilled Clinical Data Analyst II to join our team at Parexel. As a Clinical Data Analyst II, you will be responsible for performing clinical data validation activities on assigned projects, working collaboratively with the clinical study team to ensure data quality and integrity.

Key Responsibilities:
  • Perform data validation activities, including data cleaning, review, and reconciliation, to ensure data accuracy and quality.
  • Lead and support the setup of data management documents and plans, ensuring compliance with Standard Operating Procedures, ICH-GCP Guidelines, and local regulatory requirements.
  • Conduct user acceptance testing on clinical database setups and provide input on data management timelines and coordination of DM operational activities during database setup.
  • Track and review CRFs, support data entry where required, and ensure compliance to Standard Operating Procedures, ICH-GCP Guidelines.
  • Provide training and mentorship to staff and project teams as needed.
Requirements:
  • Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products.
  • Good understanding of data management processes and data validation flow.
  • Good knowledge of Clinical Data Management Systems, such as InForm, Rave, Veeva, DataLabs, and ClinBase.
  • Experience in clinical research industry and good knowledge of medical terminology and coding dictionaries.
  • Good knowledge of Data Management Operational processes and tasks during study start-up, conduct, and close-out.
  • Basic knowledge of SAS and Data standards (CDISC).
Education:

Bachelor's degree and/or other medical qualifications or relevant industry experience.

Location:

Hybrid - Bengaluru/Hyderabad/Mumbai/Mohali



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