Clinical Data Coordinator

Job Description :

Key Responsibilities:

• For Study set up activities if applicable: Responsible to design the documents like Case Report forms, Database Design documents, validation documents, CRF Completion Guidelines, performing User Acceptance Testing and preparation of other study related documents as required.
• 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 not limited to discrepancy management and communication for identified issues.
• 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 study 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 in coordination with stake holders to assist in the resolution of database related issues and/or escalating communication to the Lead Clinical Data Manager for more complex clinical issues.
• Understands how data related issues can impact analysis and reporting and applies the escalation path appropriately considering the Manage external data handling and reconciliation of external data against clinical database.
• Ensure continual compliance with all training requirements and actively pursue opportunities for professional development.
• Can be primary point of contact with the site facing role in the clinical data review process based on the skillset and proficiency.

Qualifications :

• Graduate degree or equivalent, Preferable Life science background.
• Minimum of 2 year of core experience in Data Management.
• Experience preferred in clinical data listing review and the use of data review tools