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• At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Organization (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline
• Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes
• At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness

Job Description

• The Clinical Study Startup, Manager oversees and manages the initiation phase of clinical studies. You will ensure that all startup activities are completed efficiently and in compliance with regulatory requirements, contributing to the successful execution of clinical trials
• Oversee the analysis of clinical trial data and its application to conduct accurate study start up forecasts
• Drive rapid, accurate, and data-driven study start up forecasts, benchmarking assumptions, scenarios and accurate planning
• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Site Start Up Services
• Establish, develop and deliver the Global Site Start Up Plan
• Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes
• Provide guidance, oversight, and training to the Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling
• Ensure standards are applied to the study start up process across project portfolios and support continuous improvement activities while developing TA-aligned strategies
• Guide the collection and analysis of all data to influence site start up timelines
• Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting
• Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these. Promptly recognize and improve potential delays and escalate non-performance
• Lead the site start up team, using the appropriate team members to help implement the Site Start Up Plan
• Drive delivery of all Takeda and CRO supported sites that are Ready To Enroll
• Resolve escalated issues identified by the site start up team in partnership with the Study Manager

Education & Competencies:

• BS degree or international equivalent in a life science
• 4 or more years of experience in Clinical Operations, Project Management, site start up, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor
• At least 2 years of direct responsibility in site activation and managing the site start up processes of clinical research studies at a sponsor or CRO
• Proficiency with software models and database structures
• Global SSU experience preferred
• Ability to explain data, facilitate decision making processes to be data driven
• Expertise in principles driving country/site start up and study start up strategies
• Please submit your CV, motivation letter, copies of your diplomas, and any reference letters