Associate Clinical Data Analyst

The Clinical Data Analyst performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role with minimal guidance and supervision from Line Manager and/or Subject Matter Expert. Further responsibilities shall include support on data validation activities, Data Management documents and data cleaning matrices e.g. Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shells for Off-line listing etc. All tasks should be performed in accordance to corporate quality standards, SOP's/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Qualifications

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 SOP's 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).