Location: Hybrid– Bengaluru/Hyderabad/Mumbai/Mohali
Knowledge and Experience:
• Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
• Good understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
• Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures
• Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)
• Good understanding of Clinical Study Team roles within Data Management
• Experience in clinical research industry.
• Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
• Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
• Good knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
• Basic knowledge of SAS (programmed listings)
• Basic knowledge of Data standards (CDISC)
Education:
• Bachelor’s degree and / or other medical qualifications or relevant industry experience.
