Study Project Manager II

Responsibilities:
- Strategic thinking: Link asset-level goals with study-level operational strategies and deliverables; contribute to study operations discussions at asset strategic meetings.
- Commitment to Quality: Ensure operational excellence and oversight for clinical studies in compliance with ICH/GCP, global regulations, and AbbVie SOPs.
- Leadership: Lead cross-functional teams with minimal supervision; manage end-to-end clinical study operations (all phases, from setup to closeout) to achieve milestones.
- Study/System Management: Apply expertise of AbbVie clinical study systems to inform clinical study design and associated systems, tools, and documents.
- Vendor Oversight: Oversee external partner collaboration (vendor selection, scope development, contract/SOW review/approval, data transfer planning, deliverable and timeline management).
- Risk Management: Proactively identify, address, and/or escalate study-related risks; recommend mitigation options.
- Coaching: Coach and mentor team members; delegate appropriately and share best practices.
- Innovation: Identify process improvements and lead changes to increase operational efficiency.

Qualifications:
- Bachelor’s degree (or equivalent) required.
- 8 years of demonstrated clinical research study management.
- Demonstrated leadership with cross-functional internal teams.
- Experience in drug, device, interventional/non-interventional, early feasibility studies.
- End-to-end study operations management experience (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).