Systems Design Analyst II

Responsibilities:
- Participate in developing common data standards and ensure systems designs comply with standards and associated protocol requirements.
- Establish and maintain methodology for designing and developing clinical trial systems, benchmarking against industry standards; optimize for functionality, end user experience, and data flow.
- Ensure TA- and program-level consistency by the design team.
- Accountable for on-time design and delivery of new clinical systems, integrations, and required changes (e.g., EDC, IRT, ePRO). Use project management tools to track study progress, plan work, anticipate issues affecting timelines/quality, and develop solutions.
- Interact with and influence DSS and cross-functional teams to achieve program and study objectives; synchronize work products with upstream/downstream dependencies.
- Ensure adherence to federal/local regulations, GCP, ICH guidelines, AbbVie SOPs, and functional quality standards; stay current on evolving local guidance.
- Coach and mentor team members and contribute to their skill development.
- Lead DSS and cross-functional innovation and process improvement initiatives.

Qualifications:
- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent; Master’s preferred.
- 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical or clinical development role; experience with common industry design/development tools required.
- In-depth knowledge of clinical trial process, including CDASH and SDTM.
- Demonstrated ability to contribute to organizational initiatives and advancement.
- Ability to influence without direct authority; coach/mentor in a matrixed environment; strong communication and analytical skills.