Project Manager, Study II

Responsibilities:
- Define and drive study level operational strategies and deliverables, linking to asset level goals
- Apply strategic, asset level thinking and innovative problem-solving to study planning and execution
- Execute clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
- Present and contribute to discussions on study operations at asset level strategic meetings
- Lead clinical operations planning through execution in a cross-functional matrix environment; influence stakeholders to drive milestone achievement
- Lead cross-functional teams with minimal supervision using strong critical thinking and experience
- Own end-to-end clinical study operations management (all phases, set up to close out)
- Coach and mentor team members; delegate and empower appropriately; contribute to Development Operations community
- Provide leadership through high-level cross-functional stakeholder management and influencing
- Drive operational efficiencies and foster a culture of innovation
- On assigned studies: develop clinical study design and associated systems, tools, documents; create and oversee study budget
- Manage vendor selection, scope development, and oversight of external vendors
- Proactively identify risks and address and/or escalate study issues and efficiency opportunities
- Serve as an empowered decision-maker for operational aspects of study execution

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