Clinical Validation Lead

Job Title Clinical Validation Lead Job Description Clinical Validation Lead Your Role: • Clinical leadership: Act as the global clinical lead within the project core team, representing clinical expertise and coordinating contributions from relevant subject matter experts. • End-user advocacy: Represent the voice of the end user and ensure that clinical needs, workflows, patient and user safety, and usability considerations are incorporated into project requirements and decisions. • Project coordination: Lead and coordinate application-related activities within PDLM/MLD projects across the I2M project lifecycle, ensuring timely completion of milestones and deliverables. • Validation strategy and execution: Define, align, and drive the clinical validation strategy, including the planning, preparation, execution, and reporting of user validation activities. • Compliance and quality: Ensure that Application Specialist activities and validation deliverables are executed in accordance with applicable quality processes, regulatory requirements, standards, and internal procedures. • Deliverable ownership: Lead the development and review of high-quality validation documentation, usability-related outputs, and clinical training and learning materials. • Cross-functional collaboration: Work closely with Design and Usability Engineering, Software and Systems Engineering, Product Management, R&D Clinical/Medical, Service, Solution Innovation, and other relevant functions. • Requirements integration: Facilitate the translation of clinical and user needs into clear, testable requirements and support their integration into technical development and product design. • Stakeholder alignment: Proactively engage internal and external stakeholders to establish alignment on clinical requirements, validation approaches, usability objectives, deliverables, timelines, and risks. • Decision support: Act as the interface between clinical, technical, and business teams, providing clinical evidence and expert input to support informed project decisions. • Risk and issue management: Identify, communicate, and support the resolution of clinical, validation, usability, and application-related risks or issues that may affect project outcomes. • Knowledge enablement: Promote the effective transfer of clinical and application knowledge to project teams, trainers, service organizations, and other relevant stakeholders. • Continuous improvement: Contribute to the improvement of clinical validation methods, templates, processes, and ways of working based on project experience and organizational learning.   You're the Right Fit If: • Minimum required Education: Advanced expertise in Magnetic Resonance (MR) imaging is essential. The candidate must have comprehensive formal education or recognized advanced training in MR imaging, supported by substantial knowledge of MR physics, imaging techniques, clinical applications, image quality, safety principles, and clinical workflows. • Minimum required Experience: At least five years of professional experience in MR imaging, including practical experience with MR imaging techniques, clinical applications, image quality, safety principles, and clinical workflows. You will stand out if you also have: Preferred Skills: • Strong knowledge Clinical knowlegde in MR-Imaging • Knowledge in clinical validation, and medical device quality and regulatory requirements. • Ability to translate clinical and user needs into test cases. • Proven cross-functional leadership and stakeholder management skills. • Strong communication, facilitation, and decision-support capabilities. • Experience in validation planning, execution, reporting, and risk management. • Ability to develop clear, high-quality validation documentat