Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used

Ensures that systems are specified to optimize on functionality, end user experience, and data flow

Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,).

Utilizes project management tools to track study progress and plan work.

Anticipates and identifies issues that could affect timelines or quality and develops options and solutions

Ensures that TA- and program-level consistency is achieved

Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies

Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development

Responsible for coaching and mentoring Data Science Associates

Participates in DSS and cross-functional innovation and process improvement initiatives

Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred

Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred

Senior Analyst, Clinical Data Systems

Responsibilities

Qualification

Required

Preferred

Benefits

Company

AbbVie

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