Senior EDC Lead

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

Responsibilities:
- Participate in development of common data standards; ensure system designs comply with standards and protocol requirements.
- Establish and maintain methodology for designing/developing clinical trial systems; benchmark against industry standards; optimize functionality, end-user experience, and data flow.
- Ensure TA- and program-level consistency.
- On-time design and delivery of new clinical systems, integrations, and required changes (e.g., EDC, IRT, ePRO); use project management tools; anticipate issues affecting timelines/quality and develop options/solutions.
- Influence CDO and cross-functional teams to meet program/study objectives; synchronize work products with upstream/downstream dependencies.
- Ensure adherence to regulations and standards (federal/local regulations, GCPs, ICH guidelines, AbbVie SOPs, functional quality standards).
- Coach and mentor team members and contribute to 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 experience required; Veeva EDC experience a plus.
- In-depth knowledge of clinical trial process.
- In-depth knowledge of CDASH (required) and SDTM.
- Demonstrated influence without direct authority; coaching/mentoring in a matrixed environment; strong communication and analytical skills.