Study Project Manager II
$124,500–$236,500 year
Hybrid · Irvine, California, United States
Job Summary
The Study Project Manager II drives the connection between the asset and operational delivery and execution of clinical research studies. Leads delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet objectives. Applies asset-level thinking, strategic planning, and cross-functional collaboration to address risks and optimize study operations. Responsible for oversight of quality, vendor relationships, risk management, and coaching of team members; mentors staff and identifies process improvements to enhance operational efficiency. Role requires leadership across cross-functional teams, familiarity with ICH/GCP and AbbVie SOPs, and hands-on management of end-to-end clinical study operations across multiple phases. Based in Irvine, CA with hybrid in-office presence (onsite Tue/Wed/Thu).
Required Qualifications
- Bachelor’s Degree or equivalent
- 8 years of demonstrated clinical research study management
- Demonstrated leadership and experience with cross-functional internal teams
- Experience in drug, device, interventional and non-interventional studies
- End-to-end study management from initiation through close-out in Phase 1-4
- Well versed in AbbVie SOPs and ICH/GCP regulations
- Experience with AbbVie clinical trial systems (EDC, IRT, CTMS, eTMF)
Desired Qualifications
- Bachelor’s Degree or equivalent
- 8 years of demonstrated clinical research study management
- Experience in cross-functional teams
- Experience with drug, device, interventional and non-interventional studies
- End-to-end study operations (initiation through close-out) in Phase 1-4
- Well versed in ICH/GCP regulations and AbbVie SOPs
- Experience with clinical trial systems (EDC, IRT, CTMS, eTMF)
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