Senior Clinical Study Project Lead

BioSpace; Irvine (CA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Study Project Manager II in Irvine, CA. The role drives asset-to-study delivery, leading operational strategies to execute clinical studies with quality and efficiency. Collaboration with cross-functional teams and mentorship of colleagues are key components.

The position requires deep experience in clinical study operations across phases 1–4, familiarity with ICH/GCP, and proficiency with common trial systems. Hybrid work schedule with onsite days Tue-Thu.

Qualifications

• Bachelor's degree or equivalent required.
• 8 years of demonstrated clinical research study management.
• Experience with cross-functional internal teams.
• Experience in drug, device, interventional and non-interventional studies.
• End-to-end study operations experience.
• Familiarity with AbbVie SOPs and ICH/GCP.

Responsibilities

• Provide strategic guidance linking asset goals to study operations.
• Ensure studies are executed with quality, on-time and within budget.
• Lead cross-functional teams with minimal supervision.
• Input on clinical study design, systems, tools and documents.
• Oversee vendor collaboration and contract-related activities.
• Identify and mitigate study risks; implement solutions.
• Coach and mentor team members; share best practices.
• Identify process improvements to increase operational efficiency.

Skills

Leadership

Strategic thinking

Risk management

Mentoring

Stakeholder management

Education

Bachelor's degree or equivalent

Tools

EDC

IRT

CTMS

eTMF

Job description

AbbVie is seeking a Study Project Manager II in Irvine, CA. The role drives asset-to-study delivery, leading operational strategies to execute clinical studies with quality and efficiency. Collaboration with cross-functional teams and mentorship of colleagues are key components.

The position requires deep experience in clinical study operations across phases 1–4, familiarity with ICH/GCP, and proficiency with common trial systems. Hybrid work schedule with onsite days Tue-Thu.