Study Project Manager II

The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leads clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. Contributor and leader in cross-functional teams; mentors/coach for team members.

Responsibilities:
- Strategic thinking linking asset goals to study operational strategies and deliverables.
- Ensure operational excellence in compliance with ICH/GCP, global regulations, and AbbVie SOPs.
- Lead cross-functional teams; manage end-to-end clinical study operations (set up to close out) to drive milestone achievement.
- Provide input on clinical study design and associated systems, tools, and documents.
- Vendor oversight: vendor selection, scope development, contract/SOW review/approval, data transfer planning, deliverable and timeline management.
- Proactively identify, address, and/or escalate study risks; mitigate risk with solutions.
- Coach/mentor team members; delegate and empower appropriately; share best practices and lessons learned.
- Identify process improvements and lead changes to improve operational efficiencies.

Qualifications:
- Bachelor’s degree or equivalent required.
- 8 years of demonstrated clinical research study management.
- Leadership experience with cross-functional internal teams.
- Experience with drug/device, interventional and non-interventional, early feasibility studies.
- End-to-end study operations management from initiation through completion in Phase 1–4 drug and/or device studies.
- Knowledge of AbbVie SOPs and ICH/GCP regulations.
- Expertise with clinical trial systems (e.g., EDC, IRT, CTMS, eTMF).

Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.

Work location: Irvine, CA (Hybrid; onsite Tue/Wed/Thu).