Senior Clinical Data Associate

Overview

The Senior Clinical Data Associate provides data management support across the clinical trial data management process, from study start up through post database lock, for assigned projects under direct supervision.

What you'll do

• Support the Lead DM as a backup and/or team member to ensure continuity and timely task completion.
• Perform data entry for paper-CRF studies as needed.
• Conduct quality control of data entry and help meet clinical data management deadlines with quality.
• Assist with developing CRF specifications from the clinical study protocol and coordinate stakeholder review/feedback.
• Build clinical databases, run database build UAT, and maintain quality-controlled build documentation.
• Review and query clinical trial data according to the Data Management Plan.

What you'll need

• Minimum of 5+ years of experience.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional use of English (written and oral).
• Basic knowledge of drug, device and/or biologic development and data management practices.
• Basic knowledge of ICH-GCP and regulatory guidance and ability to implement.

Details

• Location: Bangalore, Karnataka, India.
• May require some travel.