Responsibilities:
- Participate in development of common data standards and ensure clinical system designs comply with standards and protocol requirements.
- Establish and maintain methodology for designing/developing clinical trial systems; specify systems to optimize functionality, end-user experience, and data flow.
- Ensure TA- and program-level consistency.
- Lead on-time design and delivery of new clinical systems, integrations, and required changes (e.g., EDC, IRT, ePRO); use project management tools; anticipate and resolve timeline/quality risks.
- Influence DSS and cross-functional teams to achieve program/study objectives; synchronize deliverables with upstream/downstream dependencies.
- Ensure adherence to federal/local regulations, GCP, ICH guidelines, AbbVie SOPs, and quality standards.
- Coach and mentor team members; contribute to skill development.
- Lead innovation and process improvement initiatives.
Qualifications:
- Bachelorโs degree in business, MIS, computer science, life sciences, or equivalent (Masterโs preferred).
- 5+ years clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical/clinical development role; experience with common industry design/development tools.
- In-depth knowledge of clinical trial process, CDASH, and SDTM.
- Proven ability to influence without direct authority; coach/mentor in a matrixed environment; strong communication and analytical skills.
Benefits (if applicable in description):
- Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.