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Digital Health R&D
4 months ago
We’re looking for people who are determined to make life better for people around the world.
Connecting Patients and Technology:
Digital Health (DH) R&D Clinical Data Associate offers the unique opportunity to connect a passion for patients, clinical development and technology by leading the execution of Digital Health Technologies (DHTs) in clinical studies to passively and objectively measure disease-relevant physiology in support LY drug development and Lilly’s digital health products. In this role, you will also be engaged with developing and validating digital biomarkers and ultimately, digital measures which can have significant Regulatory, patient and clinical trial impact.
Purpose of the Role:
The purpose of the DH R&D Clinical Data Associate role is to be responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards.
The DH R&D Clinical Data Associate role closely partners with the broader DH R&D team (most notably Data Engineering and Clinical Operations), cross-functional scientists and colleagues, stakeholders and third-party providers to define, implement, and deliver clinical data management packages primarily for non-LY exploratory DH R&D trials via a key role in the Digital Health Innovation Hub being established in Singapore at the Lilly Centre for Clinical Pharmacology.
Primary Responsibilities:
Portfolio Strategy, Planning and Delivery
Define Lilly business requirement for the study for vendors to deliver and ensure vendor performance
Ensure that data management deliverables are delivered to scope, cost, and time objectives
Partner with DH R&D Data Engineering to execute project monitoring and quality oversight of sourcing providers for end-to-end data management activities – from study set up through trial execution through dataset delivery
Partners with DH R&D Data Engineering to drive data flow design through consultation, review, and approval of vendor work, and ensure the data flow design is aligned with the project hypothesis
Understand, define and approve key trial data and submission deliverables
Project Management
Ensure data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
Drive standards decisions, implementation and compliance for the trial in partnership with DH R&D Data Engineering and consulting other Lilly Data and Analytics colleagues
Partner with DH R&D Data Engineering, as appropriate, reviewing data to ensure database deliverables are consistent and accurate
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Minimum Qualification Requirements:
Bachelor’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences, and
Minimum of 5 years' experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)
Other Information/Additional Preferences:
Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities
Demonstrated ability to effectively partner/influence a virtual team and drive a technical project to deliver results
Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles
Knowledge of medical terminology
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.
Experience in utilizing Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Statistics, Clinical Operations, Medical)
Location: Singapore
Time Type: Full time
Travel: 0-10% travel required
About the Organization
(Lilly’s IT organization) builds and maintains capabilities using innovative technologies like most prominent tech companies. What differentiates is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best professionals from a variety of backgrounds so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business.
Lilly’s Digital Health team is focused on leveraging next generation therapeutic ecosystems, connected devices, data and analytics to transform patient experiences and improving treatment outcomes. This team is committed to meeting patients where they are, through the design and development of innovative science-driven, patient-centered health technology, such as connected devices and digital biomarkers in clinical trials and mobile apps that can deliver personalized treatment plans alongside our medicines.
Additional Information
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with
Lilly does 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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