Responsibilities:
- Help develop common data standards and ensure clinical system designs comply with standards and protocol requirements.
- Establish and maintain methodology for designing/developing clinical trial systems; benchmark against industry standards.
- Specify systems to optimize functionality, end-user experience, and data flow; ensure team expectations are met.
- Ensure TA- and program-level consistency.
- Accountable for on-time design/delivery of new clinical systems and integrations; manage required changes to systems (e.g., EDC, IRT, ePRO) using project management tools.
- Anticipate/identify issues affecting timelines or quality and develop options/solutions.
- Coordinate with DSS and cross-functional teams to achieve program/study objectives and synchronize work products with dependencies.
- Ensure adherence to regulations and guidelines (GCP, ICH, AbbVie SOPs) and functional quality standards; stay current on evolving local requirements.
- Coach/mentor team members and support their skill development.
- Lead innovation and process improvement initiatives.
Qualifications:
- Bachelorโs degree (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 required.
- In-depth knowledge of clinical trial process; CDASH and SDTM.
- Demonstrated ability to influence without direct authority; effective communication and analytical skills.
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.