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The Clinical Data Management Associate is responsible for trial level clinical data execution including database structure, content and meaning, acquisition, validation, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data standards, data collection & design, data flow management, data quality, data validation, data review, central coding, data technology, dataset delivery, adjudication coordination, archiving and decommissioning. The Clinical Data Management Associate will collaborate with the Clinical Data Associate, Clinical Study Build Programming Associate, Clinical Data Analytics Associate and key study stakeholders to define, implement, and deliver clinical data management packages for a trial or set of trials within a program.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Strategy, Planning and Delivery
• 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
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
• Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
• Represent Data and Analytics processes in cross-functional initiatives
• Actively participate in shared learning across Data and Analytics organization
Minimum Qualification Requirements:
• Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
• Job is located in Bangalore, India
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