Senior Project Manager, Clinical Trials

Cogstate develops digital cognitive assessments for clinical trials and other brain health applications. The Senior Project Manager manages multiple clinical trial and internal development projects, overseeing service delivery, client relationships, project teams, budgets, risks, and operational processes.

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:

• The Senior Project Manager will have experience with the pharmaceutical development process
• a special aptitude and interest in scientific and technical information
• an ability to motivate and mentor project and portfolio teams
• be a highly driven individual who demonstrates initiative and delivers against tight timelines in an agile environment
• The Senior Project Manager will have demonstrated experience managing a full workload of clinical projects and/or internal development projects
• a growing awareness of information technology concepts and terminology
• experience with direct and indirect people management
• confidence and composure in handling stressful situations
• problem solving
• communicating calmly and effectively with internal and external stakeholders, particularly in areas of disagreement
• Bachelor's degree in a scientific, business or a technical discipline (psychology, nursing, biology, sociology, computer science or engineering)
• Previous CNS experience
• 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)
• PMP Certification (preferred but not mandatory)
• Previous CRO experience preferable
• Supervisory/mentoring experience (preferred but not mandatory)