Job Title:
Data Strategist - Clinical Trials
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About the Role:
The Clinical Data Associate is responsible for defining trial-level clinical data strategies, including database structure, content, and meaning. This requires an in-depth understanding of data collection, flow management, quality, technology, dataset delivery, archiving, and standards. The ideal candidate will collaborate with key stakeholders to define, implement, and deliver clinical data management packages.
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Key Responsibilities:
* Define Lilly business requirements for the study/program.
* Ensure that data management deliverables are delivered to scope, cost, and time objectives.
* Execute project monitoring and quality oversight of sourcing providers for end-to-end data management activities from study set up to trial execution through dataset delivery.
* Drive data flow design through consultation and ensure the data flow design is aligned with the project hypothesis.
* Develop a Data Management Plan (DMP), maintain DMP throughout the lifecycle of the study project, and ensure DMP is followed according to study design and requirements.
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Project Management Skills:
* Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives.
* Specify the data collection tools and technology platforms for the trial/program.
* Drive and support standards decisions, implementation, and compliance for the study/program.
* Facilitate/assimilate integration of disparate data sources into datasets for decision making.
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Communication and Process Improvement:
* Act as the primary communication point for all data management activities.
* Report out status of data management milestones and data quality.
* Partner with external data vendors to understand specifications to import multiple types of data and work with technical groups to ensure timely loads of external data sets into the sponsor's database.
* Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.
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Requirements:
* A Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences, or a Bachelor's degree plus 5 or more years of experience in clinical data management or areas that closely intersect with clinical data management.
* Demonstrated ability to effectively partner/influence a virtual team and drive a technical project to deliver results.
* Proven ability to lead development of creative data solutions to address clinical development challenges.
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Benefits:
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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Additional Preferences:
* Society of Clinical Data Management certification.
* Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, 'R' and Shiny for reporting, metrics, and visualizations along with P-SQL, T-SQL for DBMS.
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