AbbVie Clinical System Design Analyst in Lake County, Illinois

Clinical System Design Analyst

USA, Illinois, Lake County

2 additional locations

USA, IllinoisUSA

Research & Development

Requisition #1900882

Purpose

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

Additional Information

  • Travel: Yes, 5 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time