Study Project Manager I - Hybrid

About the Role

The Study Project Manager I drives the connection between science and operational delivery and ensures operational excellence in planning and execution of clinical research studies across all development stages. This role is responsible for ensuring clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives by bringing scientific acumen, strategic thinking, innovation, and experience in clinical study operations management.

Responsibilities

• Defines and drives the operational strategies and deliverables for one or more clinical studies.
• Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• Proactively manages budget, timelines, and study issues; brings scientific acumen, technical expertise, and a global mindset to drive achievement of study objectives.
• Leader of the cross-functional Clinical Study Team.
• Leads clinical operations planning through to execution via a cross-functional matrix environment and influences stakeholders to drive milestone achievement.
• Effectively manages vendors and a diverse set of external stakeholders including site staff, Key Opinion Leaders, and patient groups.
• Brings a growth mindset, demonstrated by a willingness to continuously learn, grow, and adapt, give and receive feedback, and see challenges as opportunities.
• Coaches and effectively supports cross-functional team members, delegates and empowers to the right level, and actively contributes to the Development Operations community.
• Contributes towards operational efficiencies and brings innovative ideas to teams and studies.
• Demonstrates excellent communication and problem-solving skills.
• Puts patients and customers at the center of what we do.
• Navigates ambiguity and thrives even when not having all the information.
• On a given study, responsible for (but not limited to):
  • Development of the clinical study design and associated systems, tools, and documents.
  • Study budget creation and oversight.
  • Vendor selection, scope development, management, and oversight of external vendors.
  • Proactively identifying risks and addressing and/or escalating study-related issues and opportunities for efficiency.
  • Being an empowered decision-maker on operational aspects of study execution.
  • Creating an inclusive and innovative environment where staff and studies/programs will succeed.
• Provide leadership to Study Management Associates, lead, delegate, and support activities to deliver on study milestones.

Qualifications

• Bachelor’s Degree or equivalent degree is required.
• 6 years of demonstrated pharma-related and/or clinical research-related experience or equivalent required.
• Preferred exposure in study initiation through study completion in Phase 1-4 and/or Medical Device Trial Experience.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) to eligible employees.
• Eligibility to participate in long-term incentive programs.

Pay

The compensation range described is the range of possible base pay that AbbVie believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location, and may ultimately pay more or less than the posted range.