Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco and we recently opened an office in Brisbane, CA.
In this role you will be responsible for the day to day management of a clinical trial and will manage the study management team, vendors, clinical monitors and clinical trial sites. This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of own or others’ project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.
• Manages the operational aspects of clinical trials
• Participates in protocol, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
• Prepares metrics and updates for management, as assigned
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
• May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Participates in the development, review and implementation of departmental SOPs and processes
• Recommends and implements innovative process ideas to impact clinical trials management
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Serves as a liaison and resource for investigational sites
• Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Bachelor degree in a science or health related field required
• Leveling commensurate with number of years of experience.
• 5 to 6+ years of industry experience, with at least 3 years of direct clinical trial management experience at a sponsor or CRO
• Proven experience in managing CROS, specialty labs, outside vendors and international trials
• Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
• Demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
• Ability to travel up to 20% of time
• Proven ability to provide clinical expertise to a clinical development in a specified product area or project
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.