The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager II achieves these objectives by bringing scientific acumen, strategic asset level thinking, innovation, expertise in clinical study operations management and stakeholder management to address risks and challenges.

Responsibilities

• Defines and drives the study level operational strategies and deliverables – linking these to asset level goals
• Brings strategic, asset level thinking and innovative problem solving to study planning and execution
• Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• Effectively present and contribute to discussions on study operations at asset level strategic meetings
• Leads clinical operations planning through to execution via cross functional matrix environment and influences cross functional stakeholders to drive milestone achievement
• Demonstrates the skills, experience and critical thinking to lead cross functional teams with minimal supervision.
• Expertise in end-to-end clinical study operations management (all phases, set up to close out)
• Coaches and mentors team members, delegates and empowers to the right level, actively contributes to Development Operations community
• Demonstrates leadership with high level cross functional stakeholder management and influencing skills
• Lead operational efficiencies and foster a culture of innovation
• On a given study responsible for (but not limited to)
  - The development of the clinical study design and associated systems, tools and documents
  - Study budget creation and oversight
  - Vendor selection, scope development, management and oversight of external vendors
  - Proactively identifying risks and address and/or escalate study related issues and opportunities for efficiency
  - Empowered decision maker on operational aspects of study execution.