Senior EDC Lead

Purpose:
AbbVie Data Science brings people, process, and technology together to generate business value from clinical trials data and ensures 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 methodology for designing/developing clinical trial systems, benchmarking against industry standards; optimize for 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); use project management tools to track progress; identify risks to timelines/quality and develop solutions.
- Influence CDO and cross-functional teams; synchronize deliverables 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.
- Lead CDO 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 hands-on technical study build in EDC; Medidata RAVE technical study build required; Veeva EDC experience a plus.
- In-depth knowledge of clinical trial process.
- In-depth knowledge of CDASH (required) and SDTM.
- Demonstrated ability to influence without direct authority; effective communication and analytical skills.

Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for short-term incentive programs.