Project Manager, Study I

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.
• Leads one or more cross-functional Clinical Study Teams, guiding clinical operations from planning through execution in a matrix environment.
• Influences cross-functional stakeholders to drive milestone achievement.
• Effectively manages vendors and a diverse set of external stakeholders, including site staff, Key Opinion Leaders, and patient groups.
• Demonstrates a growth mindset, continuously learning, adapting, and seeing challenges as opportunities.
• Coaches and supports cross-functional team members, delegates appropriately, and actively contributes to the Development Operations community.
• Contributes to operational efficiencies and brings innovative ideas to teams and studies.
• Exhibits excellent communication and problem-solving skills.
• Prioritizes patients and customers in decision-making.
• Navigates ambiguity and thrives in situations with incomplete information.
• Responsible for study-related tasks, including:
  • Development of clinical study design and associated systems, tools, and documents.
  • Study budget creation and oversight.
  • Vendor selection, scope development, and management of external vendors.
  • Proactively identifying risks and addressing or escalating study-related issues.
  • Empowered decision-making on operational aspects of study execution.
  • Creating an inclusive and innovative environment for staff and studies.
  • Providing leadership to Study Management Associates to deliver on study milestones.

Qualifications

• Bachelor’s Degree or equivalent 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 including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.

Applicable only to applicants in locations with pay disclosure requirements: Individual compensation within the posted range will depend on factors such as geographic location. The range may be modified in the future.