Senior Analyst, Clinical Data Systems
About The Position
AbbVie Data Science brings together people, processes, and technology to generate business value from clinical trial data. The Senior Analyst, Clinical Data Systems helps ensure successful delivery of program- and study-level responsibilities assigned to Data and Statistical Sciences. The role ensures that clinical systems reflect study protocol requirements, use common data standards, and are designed to support functionality, end-user experience, and data flow. It is accountable for the timely design and delivery of clinical systems, integrations, and required system changes, while supporting study progress, quality, regulatory compliance, and cross-functional coordination. The position also contributes to process improvement and innovation and coaches and mentors Data Science Associates.
Requirements
- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent.
- At least 3 years of clinical technology experience (e.g., EDC, IRT, ePRO), or at least 5 years of experience in a similar technical role or a clinical development role.
- Demonstrated understanding of the clinical trial process.
- Knowledge of CDASH and SDTM.
- Demonstrated ability to influence others without direct authority.
- Effective communication skills.
- Effective analytical skills.
Nice To Haves
- Master’s degree.
- Experience with common industry design and development tools.
Responsibilities
- Ensure study protocol requirements are reflected in systems designs and common data standards are used.
- Ensure systems are specified to optimize functionality, end-user experience, and data flow.
- Account for the on-time design and delivery of new clinical systems, integrations between systems, and required changes to clinical systems such as EDC and IRT.
- Use project management tools to track study progress and plan work.
- Anticipate and identify issues that could affect timelines or quality, and develop options and solutions.
- Ensure therapeutic-area and program-level consistency.
- Interact with and influence Data and Statistical Sciences and cross-functional team members to achieve program and study objectives.
- Ensure assigned work products are synchronized with upstream and downstream dependencies.
- Ensure adherence to federal and applicable local regulations, Good Clinical Practices, ICH Guidelines, AbbVie Standard Operating Procedures, and functional quality standards.
- Stay current on new or evolving local regulations, guidelines, and policies related to clinical development.
- Coach and mentor Data Science Associates.
- Participate in Data and Statistical Sciences and cross-functional innovation and process-improvement initiatives.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
