Study Project Manager II

AbbVie • Irvine, CA

6h

About The Position

The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager II achieves these objectives by bringing scientific acumen, strategic asset level thinking, innovation, expertise in clinical study operations management and stakeholder management to address risks and challenges. Contributor and leader in cross-functional teams and mentor/coach for team members.

Requirements

• Bachelor’s Degree or equivalent degree is required
• 8 years of demonstrated clinical research study management
• Demonstrated leadership and experience with working with cross-functional internal teams
• Experience in: drug, device, interventional and non-interventional, early feasibility studies
• Previous study management in end to end study operations, from study initiation through study completion in Phase 1-4 drug and/or device studies
• Well versed in AbbVie’s SOPs (as well as ICH/GCP regulations)
• Expertise with Abbvie clinical trial systems (e.g., EDC, IRT, CTMS, eTMF)

Responsibilities

• Strategic thinking: Ability to link asset level goals with study level operational strategies and deliverables. Uses strategic, asset level thinking in innovative problem solving. Effectively present and contribute to discussions on study operations at asset level strategic meetings.
• Commitment to Quality: Responsible for operational excellence in all aspects of oversight for clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie SOPs
• Leadership: Demonstrates skills, experience and critical thinking to lead cross functional teams with minimal supervision; demonstrating expertise in end-to-end clinical study operations management (all phases, set up to close out) to drive milestone achievement.
• Study / System Management: For study planning, able to leverage understanding and expertise of Abbvie clinical study systems, and provide input on the development of the clinical study design and associated systems, tools and documents.
• Vendor Oversight: Provide oversight on collaboration with external partners including: vendor selection, scope development, contract review, SOW review/approval, data transfer planning and deliverable and timeline management.
• Risk Management: Using past experience and knowledge of quality standards, able to proactively identify risk, address and/or escalate study related issues; provide solutions and options to mitigate risk
• Coaching: contributes to Specialized Clinical Operations culture of supporting growth; Coaches and mentors team members, delegates and empowers to the right level, shares lessons learned, best practices and influencing skills training
• Innovation: Identify process improvements and lead changes for improvement of operational efficiencies supporting and fostering a culture of innovation.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level