Clinical Study Manager

About the role

The Alliance for Clinical Trials in Oncology Foundation (the Foundation) is seeking a Clinical Study Manager in Chicago. The role covers project management and clinical study management for studies run by the Alliance, including collaboration with industry partners on NDA and non-NDA registration trials, on-site monitoring management and participation in quality management of assigned trials.

Key responsibilities

• Identify, assess, document and manage study risks and operational issues, and develop mitigation and corrective actions
• Develop project plans, schedules, resource plans and status reports, and coordinate cross-functional teams
• Lead study development and the operational planning, conduct and management of studies from initiation to completion
• Review study materials such as monitoring reports and clinical trial agreements, and support budget development
• Take part in vendor identification, selection and contracting, and oversee vendor performance and deliverables
• Work with Regulatory, Quality and other staff to maintain inspection readiness, and track progress against milestones, budget and accrual goals
• Act as project manager for industry collaborations, representing them on the cross-functional team and serving as primary contact for industry partners
• Analyze study performance metrics, oversee site performance (enrollment, conduct, protocol compliance) and lead accrual enhancement initiatives
• Conduct site visits and meetings with investigators, physicians, vendors and consultants, and oversee monitoring CROs
• Contribute to study reports and presentations, and take part in quality management, including the Quality Monitoring and Management Committee

Required profile

• BA/BS degree
• At least 3 years of pharmaceutical, biotech, CRO or site experience in clinical research
• Study management experience and knowledge of the drug development process, ICH-GCP, applicable FDA regulations and clinical research requirements
• Preferred: oncology research experience, CRO/vendor oversight, stakeholder management, technical/medical writing, and experience managing study plans, budgets and timelines
• Ability to travel less than 10%

Required skills

• Proficiency in Microsoft Office and business-level computer skills
• Demonstrated knowledge of EDC and other clinical systems
• Excellent organizational, leadership and problem-solving skills, and strong written and verbal communication

What we offer

• 8 weeks of paid time off in year one (PTO, sick, holidays)
• Medical, dental and vision plans with a 100% employer-paid option
• Tuition reimbursement stipends and continuing education
• 3% employer match for retirement investments
• Annual employee performance bonus and cost of living adjustment
• 50% commuter reimbursement