Study Project Manager II
AbbVie
August 31, 2026
Remote friendly (Irvine, CA)
United States
$124,500 - $236,500 USD yearly
Clinical Research and Development
The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies, ensuring studies are executed with quality and efficiency, on-time, within budget, and meet company objectives.
Responsibilities:
- Strategic thinking to link asset level goals with study level operational strategies and deliverables.
- Ensure operational excellence in oversight for clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie SOPs.
- Lead cross-functional teams with end-to-end clinical study operations management (set up to close out) to drive milestone achievement.
- Leverage clinical study systems expertise to provide input on study design and associated systems/tools/documents.
- Provide vendor oversight (selection, scope, contract/SOW review/approval, data transfer planning, deliverables/timeline management).
- Proactively identify, address, and/or escalate study risks; provide mitigation options.
- Coach and mentor team members; share best practices and lessons learned.
- Identify process improvements and lead operational efficiency changes.
Qualifications:
- Bachelor’s Degree or equivalent required.
- 8 years of demonstrated clinical research study management.
- Leadership experience working with cross-functional teams.
- Experience in drug/device, interventional/non-interventional, and early feasibility studies.
- End-to-end study operations management (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 (as stated): paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Responsibilities:
- Strategic thinking to link asset level goals with study level operational strategies and deliverables.
- Ensure operational excellence in oversight for clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie SOPs.
- Lead cross-functional teams with end-to-end clinical study operations management (set up to close out) to drive milestone achievement.
- Leverage clinical study systems expertise to provide input on study design and associated systems/tools/documents.
- Provide vendor oversight (selection, scope, contract/SOW review/approval, data transfer planning, deliverables/timeline management).
- Proactively identify, address, and/or escalate study risks; provide mitigation options.
- Coach and mentor team members; share best practices and lessons learned.
- Identify process improvements and lead operational efficiency changes.
Qualifications:
- Bachelor’s Degree or equivalent required.
- 8 years of demonstrated clinical research study management.
- Leadership experience working with cross-functional teams.
- Experience in drug/device, interventional/non-interventional, and early feasibility studies.
- End-to-end study operations management (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 (as stated): paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.