AbbVie Clinical System Design Analyst in Lake County, Illinois
Clinical System Design Analyst
USA, Illinois, Lake County
2 additional locations
Research & Development
The Data Science organization is responsible for bringing people, processes, and technology together to generate business value from clinical trial data. The System Design Analyst I performs design activities related to core trial-specific systems. They ensure consistent user interfaces and system standards across clinical trials as appropriate, providing an optimal end-user experience through well-defined system designs.
Accountable for seamless execution of assigned deliverables following quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures) and defined department level processes.
Ensure compliance to established data standards to be used in the design and development of clinical trial systems
Maintain best practices to be used in the design and development of clinical trial systems, benchmarking against industry standards
Develop an in-depth understanding of the protocol for assigned clinical trials
Accountable for the on-time design and delivery and changes of clinical systems (e.g. EDC, IRT, and ePRO) during the lifecycle of the clinical trial based on the requirements of the protocol.
Engage with other members of the cross-functional and internal study teams in order to execute assigned activities.
Utilize operational data and analytical tools to optimize execution of the assigned clinical trials and to identify key areas of risk that may require escalation
Support organizational interests related to critical governance, quality and compliance, and regulatory agency inspections
Participate in department level innovation and process improvement initiatives
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
Must have 3+ years of clinical technology experience (eg. EDC, IRT, ePRO) or 5+ years of experience in a similar technical or clinical development environment. Medidata Data Rave design experience preferred.
Demonstrated understanding of clinical trial process
Knowledge of CDASH and SDTM
Demonstrated understanding of International Conference on Harmonization (ICH) guidelines and global regulations, ethics, and compliance associated with clinical research.
Demonstrated performance as a key contributor to initiatives and advancement of their organization.
Demonstrated ability to influence of others without direct authority.
Competent in application of standard business procedures.
Demonstrated effective communication skills and analytical skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Travel: Yes, 5 % of the Time
Job Type: Experienced