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 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: - 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. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.