Hybrid Study Project Manager II - Clinical Operations

BioSpace; Irvine (CA); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie in Irvine, CA is seeking a Study Project Manager II to drive operational delivery of one or more clinical studies. You will lead cross-functional teams, ensuring quality, on-time delivery within budget, and stakeholder alignment at asset and study levels.

The role requires expertise in end-to-end study operations, AbbVie systems, and strong leadership with a track record in Phase 1–4 trials. Hybrid onsite schedule includes Tue-Thu in the Irvine office.

Qualifications

• Bachelor's degree required or equivalent.
• 8+ years of demonstrated clinical research study management experience.
• Proven leadership with cross-functional internal teams.
• Experience in drug, device, interventional and non-interventional studies.
• End-to-end study operations from initiation to closeout in Phase 1–4.
• Familiarity with ICH/GCP regulations and AbbVie SOPs.
• Expertise with AbbVie clinical trial systems (EDC, IRT, CTMS, eTMF).

Responsibilities

• Strategic thinking: link asset goals with study operations and contribute to asset-level meetings.
• Quality commitment: ensure operational excellence in compliance with ICH/GCP and AbbVie SOPs.
• Lead cross-functional teams with minimal supervision and drive milestones.
• Provide input on study design and associated systems, tools, and documents.
• Oversee vendor collaboration, including SOW review and data transfer planning.
• Identify and mitigate risks; propose solutions to address study issues.
• Coach and mentor team members, share best practices and lessons learned.
• Identify process improvements to enhance operational efficiency and innovation.

Skills

Clinical study management

Leadership

Cross-functional collaboration

Strategic thinking

Risk management

Coaching

Process improvement

Education

Bachelor's degree or equivalent

Tools

EDC

IRT

CTMS

eTMF

AbbVie trial systems

Job description

AbbVie in Irvine, CA is seeking a Study Project Manager II to drive operational delivery of one or more clinical studies. You will lead cross-functional teams, ensuring quality, on-time delivery within budget, and stakeholder alignment at asset and study levels.

The role requires expertise in end-to-end study operations, AbbVie systems, and strong leadership with a track record in Phase 1–4 trials. Hybrid onsite schedule includes Tue-Thu in the Irvine office.