Clinical Trial Manager/Senior Clinical Trial Manager
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POST DATE 9/14/2016
END DATE 11/9/2016
Ultragenyx Pharmaceutical Inc.
JOB DESCRIPTIONAPPLY 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