CDS Associate Job in Bangalore at Lilly

Lilly is hiring for the role of CDS Associate!

Responsibilities of the Candidate:

• Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data
• Ensure that data management deliverables are delivered to scope, cost, and time objectives
• Coordinate end-to-end data management activities – from study set up through trial execution through dataset delivery, including on time delivery of a quality, locked database
• Ensure flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
• Contribute to key deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
• Participate in submission, inspection and regulatory response activities
• Central coding activities completed
• Archiving and decommissioning of study related data management documents and content
• Ensure that data acquisition, database design, data validation, data review, central coding and observed dataset requirements are reflective of specific protocol objectives
• Adhere to standards decisions, implementation, and compliance for the study/program
• Track and report out key study build, execution and data deliverable metrics
• Help create scope scenarios and negotiate outcomes with study teams while considering the cost and value
• Facilitate the integration of disparate data sources into datasets for decision making
• Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
• Apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
• Seek and implement means of improving processes to reduce cycle time and decrease work effort
• Represent data and analytics processes in cross-functional initiatives
• Participate in shared learning across Data and Analytics organization

Requirements:

• Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy