Systems Design Analyst II

Responsibilities
- Actively participate in the development of common data standards and ensure clinical system designs comply with standards and associated protocol requirements.
- Establish and maintain methodology for designing and developing clinical trial systems; benchmark against industry standards and optimize functionality, end-user experience, and data flow.
- Ensure TA- and program-level consistency.
- Accountable for on-time design and delivery of new clinical systems, integrations, and required changes (e.g., EDC, IRT, ePRO). Track study progress using project management tools; anticipate and resolve issues affecting timelines or quality.
- 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, GCPs, ICH Guidelines, AbbVie SOPs, and functional quality standards; stay current on evolving regulations and policies.
- Coach and mentor team members; 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 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; CDASH and SDTM.
- Demonstrated contributor to organizational initiatives and advancement.
- Ability to influence others without direct authority; coach/mentor in a matrix environment; strong communication and analytical skills.