Site Monitoring Lead

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:
ultra focused - Work together to fearlessly uncover new possibilities
The Site Monitoring Lead (SML) is responsible for partnering with the Lead Study Manager (LSM) to develop the monitoring strategy for the study and will be the primary point of contact for study-specific questions from both the internal and where applicable CRO team for monitoring. The SML will support the LSM in development, adherence and oversight to the monitoring strategy and will escalate issues as applicable. The SML, where assigned, will oversee Site Monitors (SM), ensuring consistency across a study for monitor training, monitor report review, monitoring oversight, and overall site monitor activities.
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 study level management of SMs for clinical study site/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Clinical Monitoring Plan, and associated documents.
• Conduct study start up activities where applicable at the site level including but not limited to SQV, SIV (as applicable), including management of issues that may compromise time to site activation and/or initiation.
• Partners with CRO/monitor and Lead Study Manager (LSM) to ensure site activation and support Site Monitoring readiness in anticipation of first patient first visit.
• Support the LSM on monitoring oversight activities such as but not limited to monitor selection, site selection and other monitoring oversight activities as applicable.
• Assist LSM with creating and maintaining monitoring and/or monitoring oversight plans and study specific tools/trackers (e.g., SM FAQ, ISF Reconciliation Tool and monitoring visit tracker).
• Facilitate and/or support the LSM with study wide SM trainings and SM meetings.
• Reviews trip reports, tracks, and escalates risks to LSM.
• Provide LSM with feedback on individual SM progress at sites.
• Support the LSM in the review, tracking and reporting of monitoring and start-up metrics (e.g., CDA and contract status, site and SM performance metrics).
• Co-monitoring as needed.
• May serve as SM at study sites depending on LSM delegation and/or study needs as applicable.
• Support LSM in audit/inspection activities as needed.
• Facilitates and/or supports remote and on-Site Monitoring activities, including training visits.
• Supports the LSM in reviews, and monitoring of required regulatory documentation for study start-up, study maintenance and study closeout.
• Supports LSM in risk and issue management, including development of corrective and preventative actions, relevant to site, SM, and vendor performance.
• Supports LSM in line listing data reviews and updating site-facing data management documents.

Requirements:

• BA/BS required, with preference for BA/BS with strong emphasis in health or medical science or equivalent.
• Minimum of 3 years required of direct Site Monitoring experience in a Biopharmaceutical, Pharmaceutical or CRO company, or equivalent.
• Prior experience in oversight or management of site monitors, management of global teams is preferred.
• Experience monitoring rare and ultra-rare disease, genetic disease preferred. Monitoring metabolic disease, pediatric studies, complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Neurology, Transplant, etc. is a plus.
• Strong knowledge of GCP/ICH requirements, and ability to work within country regulatory requirements and guidelines, as applicable.
• Knowledge and application of Good Documentation Practices.
• Ability to conduct assessment of site performance and implement effective corrective actions.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Ability to analyze data/metrics and act appropriately.
• May require 25-75% travel. #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.
Pay Range
$80,700 - $99,600 USD
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.
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