**Introduction** At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most challenging problems? If so, lets talk. **Your Role and Responsibilities** As a member of the Watson Health Compliance Organization you will provide clinical study leadership and support for new and existing products. This role will be to oversee and execute clinical research studies to enable successful completion to clinical endpoints. This role requires working independently and within cross functional teams to support the studies. ***Position can be located in Cambridge, MA; Hartland, WI or work remote** **Essential Job Duties** + Develop and assist in the design of clinical studies and reports. + Oversee the conduct of multiple international clinical studies + Manage CRO and/or other outside clinical study vendors. + Manage study timelines. + Drive clinical study communication to cross-functional teams. + Support other clinical activities within the department as needed, including tasks in support of IBM-sponsored clinical studies. + Support clinical information that is within regulatory applications, as well as internal clinical file documentation to achieve market clearances in US, Canada, EU, Australia, Japan and Brazil at a minimum. + Acts as a core team member on development teams, providing clinical affairs feedback and guidance throughout the product development cycle. + Provides clinical affairs expertise at the strategic business level. + Assists with the development of clinical department policy and procedure implementation. + Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures + Participates in FDA, notified body, and other regulatory inspections as requested. + Build quality into all aspects of their work by maintaining compliance to all quality requirements + Coaches, mentors and trains junior staff members. **Required Technical and Professional Expertise** + Minimum of 15 years in healthcare medical device or life sciences pharmaceutical experience, or 8 years’ experience with job title/experience related to Clinical Affairs, Quality Engineer, Quality Systems or Regulatory Affairs + Understands medical device regulations in accordance with USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore requirements. + Proven interpersonal, communication, and negotiation skills **Preferred Technical and Professional Expertise** + Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred + Proficient knowledge of Good Clinical Practices (GCP) required, certified preferred. + Experience with medical devices; software medical devices preferred. + General understanding of product development process and design control. + Proficiency with Microsoft Word, Excel and PowerPoint required. + Effective research and analytical skills + Effective written and oral communication, technical writing and editing skills + Ability to work independently with minimal supervision **About Business Unit** IBM Watson Health is pioneering a new partnership between humanity and technology with the goal of transforming global health and revolutionizing many aspects of the medical and pharmaceutical industries, as well as government sectors. We aspire to improve lives and give hope by delivering innovation to address the world’s most pressing health challenges through data and artificial intelligence insights. **Your Life @ IBM** What matters to you when you’re looking for your next career challenge? Maybe you want to get involved in work that really changes the world? What about somewhere with incredible and diverse career and development opportunities – where you can truly discover your passion? Are you looking for a culture of openness, collaboration and trust – where everyone has a voice? What about all of these? If so, then IBM could be your next career challenge. Join us, not to do something better, but to attempt things you never thought possible. Impact. Inclusion. Infinite Experiences. Do your best work ever. **About IBM** IBM’s greatest invention is the IBMer. We believe that progress is made through progressive thinking, progressive leadership, progressive policy and progressive action. IBMers believe that the application of intelligence, reason and science can improve business, society and the human condition. Restlessly reinventing since 1911, we are the largest technology and consulting employer in the world, with more than 380,000 IBMers serving clients in 170 countries. **Location Statement** We consider qualified applicants with criminal histories, consistent with applicable law. **Being You @ IBM** IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.