Responsibilities:
- Ensure study protocol requirements are reflected in systems designs and that common data standards are used.
- Specify systems to optimize functionality, end user experience, and data flow.
- On-time design and delivery of new clinical systems, integrations, and required changes (e.g., EDC, IRT). Use project management tools to track progress, anticipate issues affecting timelines/quality, and develop options/solutions.
- Ensure TA- and program-level consistency.
- Interact with and influence DSS and cross-functional team members to achieve program and study objectives; synchronize assigned work products with upstream/downstream dependencies.
- Ensure adherence to federal/local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving local regulations/guidelines.
- Coach and mentor Data Science Associates.
- Participate in DSS and cross-functional innovation and process improvement initiatives.
Qualifications:
- Bachelorโs degree in business, management information systems, computer science, life sciences, or equivalent (Masterโs preferred).
- 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years in a similar technical role or clinical development role.
- Experience with common industry design and development tools (preferred).
- Demonstrated understanding of the clinical trial process.
- Knowledge of CDASH and SDTM.
- Ability to influence others without direct authority.
- Effective communication and analytical skills.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k).
Application instructions:
- Not provided in the text.