Project Manager - Clinical Systems

Project Leadership

• Support the end-to-end IVD product development project workstreams (assays, instruments, software)
• Assist cross-functional teams to define and project scope, timelines, milestones, and deliverables
• Work with the program and principal project managers to ensure workstreams are linked to the overall program goals.
• Develop and maintain integrated project plans and risk link up with risk management approach.
• Manage project execution to meet cost, schedule, and performance targets

Cross-Functional Coordination

• Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and Marketing
• Coordinate meetings, actions, and follow-ups across project teams
• Support clear communication of project updates and status

Regulatory & Compliance

• Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)
• Support design control processes (Design History File, risk management, validation)
• Partner with regulatory teams for submissions and approvals

Risk & Issue Management

• Identify and track project risks, issues, and dependencies
• Support development and monitoring of mitigation actions
• Escalate risks to senior project or programme managers as needed

Financial & Resource Management

• Support the management of project budgets, forecasting, and resource allocation
• Track and optimize project costs
• Ensure efficient utilization of team resources

Vendor & Partner Management

• Support the management of external partners, CROs, and suppliers
• Support the management of contracts, deliverables, and performance

Continuous Improvement

• Follow established project management processes and tools
• Contribute to improvements in PM practices and tools
• Demonstrate willingness to learn and develop PM capability