Senior Associate Manager
Lilly
Bengaluru, India
6d ago

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.

Minimum educational qualification : Graduation in life science stream. Post graduation preferred

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, 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
  • 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
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