Associate - CDS Senior Associate - CDS

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Purpose

The Clinical Data Management Associate is responsible for trial level Medical Coding activities,. This requires an in good understanding of medical dictionary 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 Medical coder 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
  
  
  

Project Management

▪ Ensure that data acquisition, database design, data validation, data review, medical coding and observed dataset requirements are reflective of specific protocol objectives.

▪ Ensure to adapt, Implement and compliant to Lilly data standards requirements and provide inputs/recommendations for the study/program as applicable.

▪ Track and report key study build, execution, and data deliverable metrics.

▪ Experienced clinical data Managers 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

Enterprise Leadership

• 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, Life Sciences, Health Information, Nursing, Pharmacy, Para Medics
• Job is located in Bangalore, India
• 3 - 5 Years of experience in Medical coding activities
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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