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Associate - Cds

Freshers years
Not Disclosed
10 Dec. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Management Associate
Location: Bangalore, India


Purpose:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader based in Indianapolis, Indiana, and we strive to bring life-changing medicines to those who need them. We’re looking for people who are determined to make life better for people globally.

As a Clinical Data Management Associate, you will be responsible for the trial-level execution of clinical data, including database structure, validation, storage, retrieval, and delivery. This role requires a deep understanding of data standards, data collection & design, data quality, data validation, and the technology involved in clinical data management.

Primary Responsibilities:

The responsibilities listed below outline the general requirements for the position. These may change over time to include additional duties:

Portfolio Strategy, Planning, and Delivery:

  • Execute Lilly’s business requirements for clinical trial data management.
  • Coordinate end-to-end data management activities, from study setup through trial execution and dataset delivery.
  • Ensure timely and accurate delivery of a quality, locked database.
  • Contribute to key deliverables, including Data Management Plans, Project Plans, and observed datasets.
  • Participate in submission, inspection, and regulatory response activities.
  • Manage central coding activities and archiving/decommissioning of study-related documents.

Project Management:

  • Ensure that data acquisition, database design, validation, and review meet the specific protocol objectives.
  • Track and report key metrics for study build, execution, and data deliverables.
  • Facilitate the integration of disparate data sources into decision-making datasets.
  • Ensure compliance with internal, external, and regulatory standards (e.g., FDA, ICH, GCP, PhRMA).
  • Help create scope scenarios and negotiate outcomes with study teams.

Enterprise Leadership:

  • Continuously seek ways to improve processes and reduce cycle time.
  • Represent Data and Analytics processes in cross-functional initiatives.
  • Share knowledge and best practices across the Data and Analytics organization.

Minimum Qualifications:

  • Education: Bachelor’s degree in a medical field, Life Sciences, Informatics, Health Information Administration, Statistics, Information Technology, Nursing, or Pharmacy.
  • Location: Bangalore, India.

Why Join Lilly?

Lilly is committed to providing equal opportunities for individuals with disabilities and ensures that everyone has the opportunity to contribute to the workforce. If you need accommodations during the application process, please submit your request via this form.

Lilly is an equal opportunity employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.