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Senior Analyst, Clinical Data Systems (Onsite or Remote)
About the position
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program and study-level accountabilities assigned to Data and Statistical Sciences.
Responsibilities
- 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.
Requirements
- 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.
- Demonstrated understanding of clinical trial process.
- Knowledge of CDASH and SDTM.
- Demonstrated ability to influence of others without direct authority.
- Demonstrated effective communication skills.
- Demonstrated effective analytical skills.
