A sustainable process development and continuous improvement strategy is an integral part of a Quality Management System in GCP governing Research & Development (R&D). The Global Business Operations (GBO) organization resides within Clinical Development Operations to sustain an interconnected process and operations ecosystem by seamlessly empowering teams to connect ideas and create meaningful impact. The Associate Director, Strategic Change Enablement serves as a primary interface between the client and the Global Business Operations (GBO) function. Strategic partner with key stakeholders in their areas of focus throughout full lifecycle of strategic initiatives and delivery of solutions – from defining business needs, project planning, development, deployment, change management, and end user adoption – that supports operational excellence in clinical trial execution. Design clinical research processes and ensure alignment with cross-functional stakeholders.

Responsibilities

• Responsible for understanding AbbVie's Quality System and Regulations related to GXP activities and the Business Process Framework and is able to translate to stakeholders
• Thorough understanding of Clinical Trial Management Systems and other associated systems for areas of focus
• Understand the remit of GBO in order to leverage their expertise in support of initiative execution
• Design clinical research processes (e.g. through process mapping and workshops), ensuring alignment with cross-functional stakeholders, and partnering on strategy for implementation, and maintain supporting systems and documentation
• For functions supporting clinical research, facilitate design of organizational roles and responsibilities, and integrations into AbbVie’s Quality System
• Develop and deliver on initiative change management strategy, including stakeholder and impact assessments, initiative communications, content development and hosting sessions
• Manage systems and global program(s) that enable delivery of process & change management
• Strategic assessment of metrics and measures for their areas of focus