Primary Responsibilities:
Portfolio Strategy, Planning and Delivery:
- Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data
- Ensure data management deliverables are delivered to scope, cost, and time objectives
- Coordinate end-to-end data management activities – from study setup through trial execution to dataset delivery, including on-time delivery of a quality, locked database
- Ensure the 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
- Complete central coding activities
- Archive and decommission study-related data management documents and content
Project Management:
- Ensure 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 key study build, execution, and data deliverable metrics
- 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
- 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 the Data and Analytics organization
Candidate Profile:
- Bachelor’s degree in a medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
To Apply: Please visit our website and submit your application by 30th July 2024.