Senior Clinical Project Manager

Join a growing, ambitious team focused on supporting top projects in Beckman Coulter’s largest business. Beckman Coulter’s Chemistry and Immunoassay business is seeking an experienced Senior Clinical Project Manager. Reporting to the Head of Clinical Affairs, this role is integral to the business in maintaining and growing the product portfolio by generation of global clinical evidence to support product registration, post-market reporting, and marketing strategy. Combine your extensive knowledge in the global regulations that affect clinical research with the Danaher proprietary work processes in driving continuous process improvement and developing clinical team members around the globe. At Beckman Coulter, we Help Realize Life’s Potential by delivering the best diagnostic products to the laboratories, clinicians and patients who need them. Key Responsibilities: • Representing the Clinical function as a project liaison for global project teams to: o Drive functional standard work in the development of a comprehensive, global clinical evidence portfolio for multiple programs o Ensure that global market needs are designed into the plan for clinical trial investments (pre-market and post-market) o Drive the planning and execution of clinical trial timelines to meet project milestone targets o Collaborate with other functions (biostatistics, data management, regulatory, quality, R&D, etc) and external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables o Represent Clinical Affairs at regulatory body meetings to ensure program requirements are met and that clinical trials are executed in a compliant, scientifically appropriate manner • Driving clinical project teams to success with: o Use of Danaher proprietary work processes that drive Global Clinical study planning and execution o Examples of work deliverables include metrics and standard reports that measure the progression of clinical trials at the portfolio level, study level and within study. o Clinical teams produce work deliverables including clinical evidence strategy, clinical protocol, data management plan, monitoring plan and clinical report o Proactively leveraging the Danaher Business System tools and standard work to systematically measure/report/improve the overall clinical study process and compliance • Clinical subject matter expertise is actively sustained through: o Maintaining current knowledge of global evolution of regulations o Demonstrated adherence to Good Clinical Practice (GCP) global standards and department standard operating procedures for conducting clinical studies o This role is that of a high-level individual contributor with a technical leadership skill set, a willingness to mentor and provide project specific work direction to clinical team members around the world • Bachelor’s degree with 14+ years’ experience, Master’s degree with 12+ years’ experience, or PhD with 9+ years’ experience • Direct experience designing, organizing and conducting complex multicenter global clinical trials for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment (or comparable experience working in a regulated environment). • Experience in statistical analysis and management of clinical data, writing summary reports and technical articles for publication in professional journals • Experience in IVD product development with clinical trial strategy and execution (preferred) • Demonstrated experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration) and designing/executing clinical or registration programs resulting in a successful global commercial release. Experience in the successful registration of products in China is desired. • Demonstrated ability to solve problems and drive continuous process improvement • Detail-oriented; excellent verbal/written communication skills and interpersonal skills • Other device or pharmaceutical experience in cardiac, hepatic, thyroid, reproductive disease is a plus • Professional certification (such as CCRA, CCRC or RAC) is desired • Able to travel (domestic and international) up to 35% • Strong mandarin language skills (written and oral) is a plus Certifications, Licenses, Registrations: • Professional certification (such as CCRA, CCRC, RAC) is desired Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. #LI-LM1.