- Responsible for the day to day management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.
- Lead cross functional study management team meetings, including obtaining agreement on project timelines, study objectives and goals
- Conduct protocol and site feasibility assessments
- Participate in the selection of vendors, including CRO, IVRS, central lab, imaging, etc.
- Review draft protocols/protocol amendments and provide feedback on behalf of Clinical Operations
- Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, CRF Completion Guidelines, etc.)
- Provide drug supply assumptions to the clinical planning team
- Review clinical site documents (e.g., site specific informed consent forms), contracts, and payments
- Develop and maintain study timelines, enrollment dashboards, and budgets
- Responsible for managing assigned vendors (e.g., CRO, IVRS, contract CRAs, etc), associated budgets and timelines
- Serve as a liaison and resource for clinical sites
- Identify study risks, develop and implement mitigation strategies
- Oversee the creation and maintenance of the Trial Master File
- Perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates (CRAs)
- Review site visit reports
- Participate in initiatives and/or special projects, as assigned
- Participate in the development, review and implementation of departmental SOPs and processes
- May be responsible for the following activities:
- Managing Clinical Operations staff
- Provide drug supply assumptions to the clinical planning team
- Facilitate CRO/vendor selection process for assigned vendors
- Training & monitoring for CRO/vendor (Kick-off meeting)
- Prepare updates for management
- Serve as a back-up for the Program Manager on the Development Sub-team
- Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
- Minimum of 6 years of industry experience
- Full proficiency in the management and execution of international clinical trials (technical and soft skills)
- Working knowledge of ICH Good Clinical Practice guidelines
- Effective leadership of cross-functional teams
- Extensive experience in planning, risk mitigation strategies, trial budgets, and conduct of clinical trials
- Must have the ability to build and maintain positive relationships with management and peers
- Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
- 10-30% travel may be required #LI-CS1 #LI-Remote
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Senior Clinical Trial Manager - Novato, United States - Ultragenyx Pharmaceuticals Inc.
Description
Position Summary:
ultrafocused - Work together to fearlessly uncover new possibilities
The Senior Clinical Trial Manager (CTM) is responsible for providing leadership to one or more Study Management Teams (SMTs).
The Senior CTM is responsible for the day to day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites.
The Senior CTM is also accountable for ensuring high quality deliverables are within timelines and budget.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:
Requirements:
