Lilly Senior Associate Manager - CDM in Bengaluru, India
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 35,000 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.
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 businesses 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
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