Associate Clinical Data Facilitator

About the role

As Associate Clinical Data Facilitator in Global Business Services in Bangalore, you will make sure the clinical trial data behind Novo’s treatments is accurate, compliant and ready for submission. You will prepare the forms and documents regulatory authorities review, and use Python, VBA and Power BI to replace repetitive manual work with smarter, faster ways of working.

What you'll do

• Own the quality and submission-readiness of clinical data forms for your assigned trials, while making the way the team works simpler and more automated
• Compile, bookmark, merge and hyperlink sample and completed (e)CRFs, and appendices for Clinical Trial Reports and Non-interventional Study Reports
• Prepare (e)CRFs and CDISC submission documents (aCRF, cSDRG) to meet eCTD compliance standards
• Support the decommissioning of EDC and eCOA systems, including retrieval and archival of audit trails, access reports
• Manage the scanning, tracking and archival of paper-based clinical documents, such as CRFs and patient diaries, in line with records management requirements

What you need

• 2–3 yrs of experience
• Regulatory affairs
• Clinical data management
• VBA
• Power BI
• Python
• Quality control
• B.Tech or B.E. or B.Sc or BCA