Study Project Manager II

Study Project Manager II

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

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.

This role is based in our Irvine, CA office location. Hybrid schedule and the onsite days are Tuesday, Wednesday and Thursday.

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.

Qualifications:

• 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)

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Pay Range: $124500 - 236500 USD

Where We Work:

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.