Senior Analyst, Clinical Data Systems (Onsite or Remote)

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Requirements:

• 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.

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.
• 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 adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
• Responsible for coaching and mentoring Data Science Associates.
• Participates in DSS and cross-functional innovation and process improvement initiatives.