Senior EDC Lead

Purpose:
AbbVie Data Science brings people, process, and technology together to generate business value from clinical trials data; this role ensures successful delivery against program- and study-level accountabilities for the Clinical Data Strategy Organization.

Responsibilities:
- Participate in development of common data standards and ensure systems designs comply with standards and protocol requirements.
- Establish and maintain methodologies for designing/developing clinical trial systems; benchmark against industry standards.
- Ensure systems are specified to 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 system changes (e.g., EDC, IRT, ePRO); use project management tools to track progress, plan work, and develop options to address issues affecting timelines/quality.
- Influence CDO and cross-functional teams to achieve program/study objectives; synchronize work products with upstream/downstream dependencies.
- Ensure adherence to regulations (federal/local), GCP, ICH guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving local regulations.
- 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 of hands-on technical study build in EDC; Medidata RAVE technical study build required; Veeva EDC experience is a plus.
- In-depth knowledge of clinical trial process; CDASH (required) and SDTM.
- Demonstrated ability to contribute to organizational initiatives; influence without direct authority.
- Ability to coach/mentor in a matrixed environment; strong communication and analytical skills.