Manager, Global Clinical Operations Functional Excellence
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and may manage day to day functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics activities, participate in GCO vendor assessment, and tracking od vendors and assessment status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and trending to shape the future of Daiichi Sankyo clinical trials. Job Description Responsibilities Process Improvement, Innovation and Optimization (I&O): -Project manage GCO Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts. -Support the build of industry expertise in innovation and optimization for clinical trials. -Utilize strategic conferences for information mining and networking, engage more with organizations such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc. -Work with and/or support subject matter experts to determine needs and build business cases for implementation of I&O tools. -Assist with the tracking of vendors - vendor assessment status and final choices, in collaboration with R&D Procurement, who leads the vendor assessment process. -Participate with other FxExc teams within Daiichi Sankyo to optimize cross-functional improvements. -Support creation and/or maintenance of templates (tools, guidance documents, execution plans, Visio and/or Project process mapping), and/or Power Point presentations, as needed. GCO Training: -Contribute to the creation and/or maintenance of GCO Onboarding training. -Assist with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate. -Participate with the identification and implementation of learning and training related needs within GCO. Liaise with other functions and stakeholders, as needed. -Assist with the review of SOPs and training documentation resulting from new processes or process improvements and roll out GCO training and/or lessons learned, as appropriate. Metrics: -When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to: -monitor GCO processes and workstream implementations for effectiveness. -monitor key metrics and partner with process owners to identify and address gaps/deficiencies, as needed. -track and oversee the progress of GCO initiatives and goals through KPIs and metrics to monitor and evaluate risks/issues across GCO and effectiveness of initiative and/or process implementation. -Work closely with CTBO and Alliance Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements. -monitor and evaluate risks/issues across GCO initiatives Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree Bachelor's degree with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management a plus. required Experience Qualifications 4 or More Years Experience in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management) required Collaboration, influencing, and change management skills in a complex, matrix environment including project management preferred Experience in clinical trial design and improvement activities, harmonization/optimization, and training and implementation required Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point), training systems, and metrics dashboarding preferred Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements preferred Travel Requirements Ability to travel up to 10% of the time. For team meetings, conferences, and to support inspections, as appropriate. Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$127.280,00 - USD$190.920,00 Download Our Benefits Summary PDF
