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.
Position Summary:
ultradedicated – 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
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· Generous vacation time and public holidays observed by the company
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
* Benefits vary by region and country
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 talentacquisition@ultragenyx.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.
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.
