.Why Join Us?Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.Position Summary: ultracurious – Apply your biggest ideas in courageous waysThe Country Clinical Trial Manager (CCTM) is part of the Study Management Team (SMT). The CCTM is responsible for the country specific day-to-day management of a clinical trial which may include oversight of clinical monitors and clinical trial sites in one or several countries. The CCTM may also support the Lead Study Manager with tasks that might not be specific to the country/countries. The CCTM is also accountable for ensuring high quality deliverables are within timelines and budget in the respective country/ies. Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities:Responsible for the day-to-day management of assigned country specific operational aspects, such as CRO/vendor issues and escalation, drug supply management, oversight of clinical sites, etc.Manages country deliverables including start up, enrolment and end of study timelines. Responsible for country level quality and compliance with assigned protocols.Coordinates and liaises with LSM, CCOL, CRA to ensure country milestones are delivered for submissions, budgets and contracts. Collaborates closely with global team to align country timelines for assigned protocols.Conduct protocol and site feasibility assessmentsDevelop local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols
