Clinical Research Project Manager

• Oversee the coordination, execution, and management of several Phase I, II, III PI-Initiated/Multi-Center oncology trials within the Clinical Trials Office, ensuring compliance with clinical trial regulations
• Collaborate with senior managers to develop comprehensive project plans that provide direction, expectations, and milestones for participating sites
• Collaborate with the Principal Investigator (PI) to develop protocols and consent forms for initial applications and amendments
• Ensure the project team meets all deadlines and maintains ongoing relationships with the research team, Principal Investigators, and external collaborators
• Develop systems, tools, and infrastructure for clinical trial management activities, including study start-up, site activation, research staff training, regulatory submissions, and event tracking
• Prepare and present detailed status reports to key stakeholders, including information about project timelines, progress, and compliance with regulatory standards

• Bachelor's degree in a field relevant to clinical research
• Five (5) years of experience in clinical research or project management, with a focus on multi-center oncology trials, including specific experience in clinical trial operations and coordination
• In-depth understanding of clinical trial phases and multi-center trial coordination, including specific requirements for PI-initiated trials
• Knowledge of advanced regulatory requirements and compliance standards, with expertise in Good Clinical Practice (GCP) and FDA regulations
• Familiarity with project management methodologies and strategic planning, tailored to clinical trial environments
• Advanced organizational skills to manage multiple complex projects simultaneously
• Strong leadership and team coordination skills to guide research teams
• Proficient in developing project plans and tracking systems, utilizing clinical trial management software such as EPIC and OnCore
• Ability to work independently with minimal supervision
• Capability to develop and implement strategic project management solutions
• Competence in stakeholder engagement and relationship management
• Expertise in risk assessment and contingency planning
• Ability to analyze complex data sets and generate actionable insights

Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving leadership and strategic management of clinical trials