System Design Analyst II - HYBRID

Purpose:
AbbVie Data Science brings people, process, and technology together to generate business value from clinical trials data, ensuring successful delivery against program- and study-level accountabilities.

Responsibilities:
- Participate in developing common data standards and ensure system designs comply with standards and protocol requirements.
- Establish and maintain team methodology for designing/building clinical trial systems; benchmark against industry standards to optimize functionality, end-user experience, and data flow.
- Ensure TA- and program-level consistency.
- Deliver new clinical systems on time; manage integrations and required changes (e.g., EDC, IRT, ePRO) using project management tools; identify risks to timelines/quality and develop solutions.
- Influence CDO and cross-functional teams to achieve program/study objectives; synchronize deliverables with upstream/downstream dependencies.
- Ensure adherence to federal/local regulations, GCP, ICH, AbbVie SOPs, and quality standards; stay current on evolving local guidance.
- Coach and mentor team members; contribute to their skill development.
- Lead CDO and cross-functional innovation and process improvement initiatives.

Qualifications:
- Bachelor’s degree in business, MIS, computer science, life sciences, or equivalent; Master’s preferred.
- 5+ years hands-on 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 influence without direct authority; coaching/mentoring in a matrixed environment; strong communication and analytical skills.