AbbVie Clinical Data Strategy & Operations (CDSO) 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 of clinical systems against the program and

study level accountabilities assigned to Data and Statistical Sciences (DSS).

• As the Clinical Data Systems Lead, accountable for the on-time design and delivery of the clinical systems across the assigned portfolio
• Utilizes effective project management tools to track study progress and plan work.
• Proactively identifies issues that could affect timelines or quality and develops options and solutions
• Ensures study team needs are executed as per their requirements and reflected in design documents and clinical data standards (CDASH, SDTM etc.) and Protocol, are adhered to.
• Ensures that systems are specified to optimize on functionality, end user experience, and data flow along with Therapeutic Area (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 technology, process, and data flow dependencies
• Leads Clinical Data Strategy & Operations technology innovation and process improvement initiatives and may participate in broader CDSO initiatives that impact Data and Statistical Science and cross-functional study teams
• Works with the clinical system vendors for various technologies to support study portfolio
• Understands documentation and regulatory requirements to support inspection readiness
• Coaches and mentors Clinical Technology Strategy & Operations Associates
• 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