Senior Clinical Trial Manager

Position Summary:

ultra dedicated - Your biggest challenges yield rare possibilities

The Senior Clinical Trial Manager Sr. (CTM) is responsible for the day-to-day management of a clinical trial or region, oversight of vendors, and clinical trial sites. For this study, the role is as a Lead Study Manager. The Senior Clinical Trial Manager (Sr. CTM) is accountable for ensuring high quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.

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:

• Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc for assigned region(s) or study(s)
• Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
• Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc
• Lead, or actively contribute to, Study Management Team meetings
• Identify study risks, develop and implement mitigation strategies
• Oversee Trial Master File, Completeness Reviews, and Essential Document List
• Support the study budgeting process, including the review of clinical trial financial accruals
• Manages direct reports
• Represents Clinical Operations on initiatives, may lead initiatives

Requirements:

• Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Typically, 8 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred
• Fully capable to independently lead all aspects of a clinical trial
• Effective leadership of cross-functional teams
• Excellent planning, organizational, and communication skills
• Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions
• Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact
• Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
• 10% travel may be required

#LI-CS1 #LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at View email address on job-api.jobget.com .

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.