CDR - L9 & L10 - Bengaluru

Job Description:

Job Role: Clinical Data Reviewer

Purpose/Objective of the role:

The CDR position performs protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality

Key responsibilities of the role:

• Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines.
• Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning.
• Demonstrates an understanding of the indication studied and the overall clinical data review goals in meeting the objectives of the protocol. Works closely with other protocol team members to meet the appropriate timelines for data cleaning requirements at the site/protocol level
• Responsible for the identification and resolution of issues noted during clinical data listing review. Engages the Protocol Data Manager to assist in the resolution of database related issues and/or the Lead Clinical Data Reviewer for more complex clinical issues
• Understands how data related issues can impact analysis and reporting and applies the escalation path appropriately
• Proactively collaborates with other study team members to address issues related to data quality at worldwide level.
• Effectively uses available tools and systems to gather information needed to manage clinical data listing review, generate reports and to provide feedback to the appropriate client team members.
• Main point of contact with the site facing role in the clinical data review process
• Contributes to non-project task forces, work streams and initiatives.

Required Educational Background:

• Bachelor’s degree preferred in one or more of the following disciplines or related fields: Life Sciences and Allied Healthcare professionals.

Required Experience & Competencies:

• 4 to 6 years of experience in clinical data review or similar industry roles involved in data review/management
• Experience preferred in clinical data listing review and the use of data review tools