System Design Analyst I, Clinical Data Systems

Summary

AbbVie develops innovative medicines and solutions to address serious health issues across multiple therapeutic areas. The System Design Analyst I will ensure clinical trial protocol requirements, data standards, system functionality, integrations, and regulatory requirements are reflected in clinical systems designs and delivery. The role also supports cross-functional collaboration, issue resolution, process improvement, and coaching of Data Science Associates.

Responsibilities

• Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used
• Ensures that systems are specified to optimize on functionality, end user experience, and data flow
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensures that TA- and program-level consistency is achieved
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring Data Science Associates
• Participates in DSS and cross-functional innovation and process improvement initiatives

Skills

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent
• Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence of others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills
• Masters preferred
• Experience with common industry design and development tools preferred

Qualifications

Must Haves

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent
• Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence of others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Nice to Haves

• Masters preferred
• Experience with common industry design and development tools preferred

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• Eligible to participate in short-term incentive programs.
• Remote work arrangement.