Clinical Data Management Jobs Bangalore at Lilly – BSc Life Sciences Apply
Associate – CDS/Senior Associate – CDS
Location Bangalore, Karnataka, India
Category Research & Development
Job Type Full Time Regular
Job Id R-88313
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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
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