Study Project Manager - Hybrid

About the role

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.

Responsibilities

• Defines and drives the study level operational strategies and deliverables - linking these to asset level goals
• Bridges strategic, asset level thinking and innovative problem solving to study planning and execution
• Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
• Effectively presents and contributes to discussions on study operations at asset level strategic meetings
• Leads clinical operations planning through to execution via cross-functional matrix environment and influences cross-functional stakeholders to drive milestone achievement
• Demonstrates the skills, experience, and critical thinking to lead cross-functional teams with minimal supervision
• Expertise in end-to-end clinical study operations management (all phases, set up to close out)
• Coaches and mentors team members, delegates, and empowers to the right level, actively contributes to Development Operations community
• Demonstrates leadership with high-level cross-functional stakeholder management and influencing skills
• Lead operational efficiencies and foster a culture of innovation
• On a given study responsible for (but not limited to):
  • The 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 identifies risks and addresses or escalates study-related issues and opportunities for efficiency
  • Empowered decision-maker on operational aspects of study execution.

Requirements

• Bachelor’s Degree or equivalent degree is required
• 8 years of demonstrated pharma-related and/or clinical research related experience or equivalent required
• PREFERRED: Oncology Clinical Trial Experience
• PREFERRED: Exposure in study initiation through study completion in Phase 1-4 and/or Clinical Trial Experience

Qualifications

• Preferred: Exposure in study initiation through study completion in Phase 1-4 and/or Clinical Trial Experience

Skills

• Expertise in end-to-end clinical study operations management (all phases, set up to close out)
• Strong leadership and stakeholder management skills
• Ability to identify and manage risks
• Proven ability to execute projects on time and within budget
• Experience with clinical trial processes and regulatory requirements

Benefits

• Coverage of medical/dental/vision insurance
• Comprehensive package of benefits including paid time off (vacation, holidays, sick), and 401(k)
• Participation in long-term incentive programs

Pay

$124,500 - $236,500 USD

Schedule

• 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.