Associate - Clinical Trials - Clinical Data at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

In-depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving, and data standards
Therapeutic knowledge and deep understanding of technology used to review data
Knowledge of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.)
Excellent written and verbal communication skills, including ability to represent the Data and Analytics organization and influence stakeholders

Responsibilities

Define Lilly business requirements for the study/program for vendors to deliver
Ensure data management timeline and results are delivered to scope, cost, and time objectives
Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities (study set up through trial execution through dataset delivery)
Ensure vendor performance for program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
Drive data flow design through consultation, review, and approval of vendor work, ensuring alignment with project hypothesis
Approve key outputs and results (Data Quality Delivery Plan, Data lock Plan, Project Plan, database, observed datasets)
Define and approve data quality and submission outputs and results
Ensure data acquisition, database design, and observed dataset requirements reflect specific protocol objectives
Specify data collection tools and technology platforms for the trial/program
Drive standards decisions, implementation, and compliance for the study/program
Help create scope scenarios and negotiate outcomes with study teams, considering cost and value
Facilitate/assimilate integration of disparate data sources into datasets for decision making
Ensure database deliverables are consistent and accurate
Act as primary communication point for all data management activities related to a clinical study
Report out status of data management milestones and data quality
Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads into sponsor's database
Partner with cross-functional team members to ensure trial success through robust oversight

Skills

Key technologies and capabilities for this role

Clinical Data ManagementData StandardsData QualityData Flow ManagementVendor ManagementDatabase StructureDataset DeliveryData ArchivingTrial LeadershipProject Monitoring

Questions & Answers

Common questions about this position

Is this position remote or hybrid?

This is a hybrid position requiring 3 days onsite and 2 days remote.

What is the salary range for this role?

This information is not specified in the job description.

What key skills are required for this Clinical Data Associate role?

The role requires an in-depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving, and data standards, along with skills in project management, vendor oversight, and driving data flow design.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, putting people first, with employees giving their best effort to discover life-changing medicines and give back to communities.

What makes a strong candidate for this position?

Strong candidates will have experience providing trial leadership, collaborating with study partners to deliver clinical data management packages, and ensuring data management timelines meet scope, cost, and time objectives.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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