Senior Clinical Data Systems Analyst

AbbVie; North Chicago (IL); Presencial; USD 85 000 - 162 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical/dental/vision insurance

401(k)

Resumo da oferta

AbbVie Data Science is a best-in-class team responsible for bringing people, process, and technology together to generate business value from clinical trials data. This role ensures delivery against program- and study-level accountabilities and collaborates with cross-functional teams to optimize data flow and systems functionality.

The position emphasizes adherence to GCPs, regulatory guidelines, and AbbVie SOPs, with coaching responsibilities for Data Science Associates and opportunities to

Qualificações

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred
• 3+ years of clinical technology experience (EDC, IRT, ePRO) or 5+ years in a similar role; experience with common industry design and development tools preferred
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Responsabilidades

• 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 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

Conhecimentos

Communication skills

Analytical skills

Influence without authority

Formação académica

Bachelor’s degree in business, MIS, CS, life sciences or equivalent. Masters preferred

Descrição da oferta de emprego

AbbVie Data Science is a best-in-class team responsible for bringing people, process, and technology together to generate business value from clinical trials data. This role ensures delivery against program- and study-level accountabilities and collaborates with cross-functional teams to optimize data flow and systems functionality.

The position emphasizes adherence to GCPs, regulatory guidelines, and AbbVie SOPs, with coaching responsibilities for Data Science Associates and opportunities to