System Design Analyst II - HYBRID

Purpose:
AbbVie Data Science is responsible for generating business value from clinical trials data through execution and innovation for program- and study-level accountabilities.

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

Qualifications:
- Bachelor’s degree in business, management information systems, computer science, or life sciences (or equivalent); Master’s preferred.
- 5+ years technical Study build in EDC; Medidata RAVE technical study build required; Veeva EDC is a plus.
- In-depth knowledge of clinical trial processes.
- In-depth knowledge of CDASH (required) and SDTM.
- Demonstrated contribution to initiatives and organizational advancement.
- Ability to influence without authority; coach/mentor in a matrixed environment; strong communication and analytical skills.