Senior Clinical Project Manager - Gene Therapy

Company: Ultragenyx Pharmaceutical
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Senior Clinical Project Manager - Gene Therapy Cambridge, MA /

Ultragenyx - Gene Therapy – Clinical Development /

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities!  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 process will include remote based web-ex video discussions, interviews & onboarding.

The Clinical Project Manager (CPM) is responsible for providing support to one or more Study Management Teams (SMTs). The CPM is responsible for the day-to-day management of one or more clinical trial(s) and oversight of vendors, clinical monitors and clinical trial sites. The CPM is also accountable for ensuring high quality deliverables are within timelines and budget. The core duties and responsibilities of the CPM include, but are not limited to:

Responsibilities Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.

Conduct protocol and site feasibility assessments

Participate in the selection of vendors, including CRO, IVRS, central lab, imaging vendor, 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.)

Review clinical site documents (e.g., site specific informed consent forms), contracts, and payments

Develop and maintain study timelines and enrollment dashboards

Responsible for managing assigned vendors (e.g., CRO, Labs, etc), associated budgets and timelines

Support the study budgeting process, including the review of clinical trial financial accruals

Serve as a liaison and resource for clinical sites

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)

Participate in initiatives and/or special projects, as assigned

Develop and review Standard Operating Procedures

Mentor Clinical Operations staff (e.g., Clinical Trial Specialists and Clinical Trial Associates)

May be responsible for the following activities:

Provide drug supply assumptions to the clinical planning team

Training & monitoring for CRO/vendor (Kick-off meeting)

Prepare updates for management

Leading cross functional study management team meetings, including obtaining agreement on project timelines, study objectives and goals

Requirements Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)

5+ Years experience managing the day-to-day operations of clinical trials for CPM; 7+ years of experience managing day to day operations of clinical trials for Sr. CPM

Working knowledge of ICH Good Clinical Practice guidelines

Experience with international trials is preferred

Excellent planning and organizational skills

Able to handle multiple tasks and deadlines

Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

Highly effective verbal and written communication skills

Flexible and solution focused

Must have the ability to build and maintain positive relationships with management, peers and clinical sites

Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

10-30% travel may be required

#LI-CZ1 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.

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 Pharmaceutical, Cambridge , Senior Clinical Project Manager - Gene Therapy, Other , Cambridge, Massachusetts