Project Manager, Study II

Responsibilities:
- Defines and drives study level operational strategies and deliverables, linking them to asset level goals
- Applies strategic, asset-level thinking and innovative problem solving to study planning and execution
- Executes clinical studies in compliance with quality standards (ICH/GCP, global regulations, and AbbVie policies/procedures)
- Presents and contributes to study operations discussions at asset-level strategic meetings
- Leads clinical operations planning through execution in a cross-functional matrix environment and influences stakeholders to achieve milestones
- Leads cross-functional teams with minimal supervision using critical thinking and demonstrated experience
- Manages end-to-end clinical study operations (set up through close out; all phases)
- Coaches and mentors team members; delegates/empowers appropriately; contributes to the Development Operations community
- Demonstrates leadership and high-level cross-functional stakeholder management and influencing skills
- Leads operational efficiencies and fosters a culture of innovation
- Develops, on assigned studies, the clinical study design and associated systems/tools/documents; creates and oversees study budgets
- Handles vendor selection, scope development, and management/oversight of external vendors
- Proactively identifies risks and addresses/escalates study issues and efficiency opportunities
- Serves as an empowered decision maker on operational aspects of study execution

Qualifications:
- Bachelor’s degree or equivalent required
- 8 years of demonstrated pharma-related and/or clinical research related experience (or equivalent) required
- Preferred: exposure from study initiation through completion in Phase 1–4 and/or medical device trial experience