Lilly is a global leader in healthcare, dedicated to making life better for people worldwide. Headquartered in Indianapolis, Indiana, Lilly has been at the forefront of developing life-changing medicines, enhancing disease understanding, and supporting communities through philanthropy and volunteerism. At Lilly, employees work with passion and determination to bring forward medical advancements while prioritizing the well-being of people around the world.
Job Overview: The Clinical Data Management Associate at Lilly is responsible for managing clinical trial data execution, ensuring the structure, content, acquisition, validation, and storage of data. This role requires a comprehensive understanding of data standards, collection, data flow management, and the technology used to review clinical data. The Associate will collaborate closely with other stakeholders in the trial to deliver high-quality, timely clinical data management packages.
Responsibilities in the Job: As a Clinical Data Management Associate, your primary duties will include:
- Portfolio Strategy, Planning, and Delivery:
- Manage and ensure the delivery of clinical trial data within scope, time, and budget.
- Collaborate with vendors to meet the study’s data management requirements.
- Coordinate activities from study setup through data delivery, ensuring timely delivery of a high-quality locked database.
- Handle the flow of data, ensuring integration of niche data sources such as pharmacokinetics, immunogenicity, and biomarkers.
- Project Management:
- Oversee data acquisition, database design, data validation, and central coding to meet protocol objectives.
- Track and report on key deliverables and study metrics.
- Ensure compliance with regulatory requirements such as FDA, ICH, GCP, and more.
- Facilitate the integration of disparate data sources for accurate decision-making.
- Enterprise Leadership:
- Continuously improve processes to reduce cycle time and increase efficiency.
- Represent data and analytics processes across cross-functional teams.
- Actively engage in shared learning across the Data and Analytics organization.
Qualifications:
- Education: A Bachelor’s degree in a medical field such as Life Sciences, Informatics, Health Information Administration, Statistics, Nursing, Pharmacy, or related fields.
- Experience: Prior experience in clinical data management or a related field is preferred.
- Location: This position is based in Bangalore, Karnataka, India.
Skills: To excel in this role, you should have the following skills:
- Technical Expertise: In-depth understanding of clinical data management processes, database design, and data validation.
- Project Management: Strong organizational skills with the ability to track multiple tasks and deliverables.
- Communication Skills: Ability to communicate effectively across teams and with vendors.
- Regulatory Knowledge: Understanding of internal, external, and regulatory requirements (e.g., GCP, FDA, MHRA).
- Problem Solving: Ability to troubleshoot and resolve issues in data management efficiently
