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Temporary Senior Clinical Trial Manager

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: June 12, 2021

Job Description:

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. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

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.

Responsibilities including, but not limited to:

  • 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) as needed
  • 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:
  • 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 Lead on the Development Sub-team

Technical Requirements & Skills:

  • Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
  • 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
  • Excellent planning and organizational skills
  • Able to handle multiple tasks and deadlines
  • Must be self-motivating and able to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact
  • Highly effective verbal and written communication skills
  • Flexible and solution focused
  • Strong customer focus
  • 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

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. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

See our CCPA Employee and Applicant Privacy Notice.

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

Keywords: Ultragenyx Pharmaceuticals, Novato , Temporary Senior Clinical Trial Manager, Other , Novato, California

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