Senior Project Manager, Clinical Trials

Cogstate is advancing the science of brain health, aiming to improve cognition assessment across various settings. They are seeking a Senior Project Manager to oversee multiple clinical trial projects, manage client relationships, and ensure the delivery of services while navigating complex challenges in the pharmaceutical development process.

Responsibilities:

• Manage projects and execute tasks in line with company SOPs and agreed regulatory standards, including the following tasks:
• Manage client relationships as main POC for individual studies and some sponsor portfolios
• Independently lead Cogstate’s complex global clinical trials projects – including implementation of projects with new service offerings in scope, where feedback is necessary to the development and commercialization teams to improve process
• Manage Clinical Trials projects in Start-Up, Conduct or Close-Out phases (multiple projects at one time)
• Proactively manage risks with confidence, demonstrating strong leadership in guiding team members through challenges and making decisive, well-informed decisions
• Attending Investigator Meetings (as needed) and ensuring Cogstate is well represented
• Work in an Agile environment with a given Portfolio Team
• Oversight of resourcing and financials across a Portfolio of Projects- ensure team members follow pre-determined hours allocated in budget to target gross profit consistently
• Generate invoices for assigned projects in alignment with expected timelines and project progress. Maintain a strong understanding of the broader impact of invoicing on company financials
• Actively maintain the change order process
• Oversee internal projects focused on developing processes for implementing new technologies, with the ability to map, visualize, and optimize workflows to support commercialization and scaling efforts
• Develop operational deployment plans for new systems, including training, and operate as the point person for support
• Work closely with Business Development and project team managing relationship and supporting proposals for key accounts
• Potential to line manage or indirectly manage and mentor other project management team members and clinical operations staff in the future
• Analyze reports for project hours and budget utilization and making course corrections in conjunction with Operations Line Managers
• Forecast invoicing based on expected timeline and progress of the study
• Ability to review Work Orders and determine deliverables and timelines for project
• Ensure accurate reporting to internal and external stakeholders on service delivery and progress
• People/Staff management: Demonstrate high performance in mentoring other project management team members and clinical staff
• Develop/contribute to playbooks for new Sponsors/Partners/systems, including training, and operate as the point person for support
• Participate in internal and external audits and inspections
• Support metrics reporting to sponsors

Requirements:

• Bachelor's degree in a scientific, business or a technical discipline (psychology, nursing, biology, sociology, computer science or engineering)
• 7+ Years Project Management experience in Pharmaceutical, Biotech, or CRO environment
• Relationship Management Experience
• Microsoft Office proficiency
• Budget management experience
• Master's preferred (science or business) but not mandatory
• PMP Certification (preferred but not mandatory)
• Supervisory/mentoring experience (preferred but not mandatory)
• Previous CRO experience preferable
• Previous CNS experience