Case Manager, Early Access & IST Programs at Ultragenyx (Remote)

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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 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.
 
US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
 
Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.


Position Summary

ultrainnovative – Tackle rare and dynamic challenges
 
Ultragenyx is looking for a driven, compassionate and innovative Case Manager (CM) for the global Early Access (EA) and Investigator Sponsored Trial (IST) programs in the Global Development Operations department. This role is vital to achieving program goals and offers an opportunity to work on a variety of projects that reflect the company’s patient focused mission.
 
The CM is responsible for the day-to-day management and operations of expanded access clinical trials, ISTs and EA (“Compassionate Use”) cases including the management of vendors, clinical monitors and participating IST and EA sites. This position will also work closely with cross-functional teams to ensure that these programs are conducted in a timely fashion and in a manner compliant with ICH/Good Clinical Practice (GCP)/regulatory guidelines and SOPs as well as company goals and budgets.
 
Work Model:
Remote: officially documented as working full time from home, with travel to Ultragenyx's offices or other location on occasion as needed

Responsibilities:

  • Manages the operational aspects of expanded access clinical trials, Investigator Sponsored Trials (ISTs), Early Access (“Compassionate Use”) cases and Sponsored Research
  • Participates in protocol, informed consent, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Manages case/study timelines and budgets
  • Proactively identifies potential issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO/vendor interactions, providing sponsor oversight of operational activities (e.g., case management, monitoring, project master files), develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves case-related documents/templates, as appropriate (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines), and site-related documents (informed consent template and tools/worksheets), investigator contracts, and site payments
  • Manages case monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations
  • Recommends and implements innovative process ideas to impact early access clinical trials management
  • Organizes and manages internal cross-functional review meetings, team meetings, investigator meetings and other case-specific meetings, as required
  • Serves as an internal liaison and resource for Investigators/Physicians and Medical Science Liaisons (MSLs)
  • Participates in the selection, training and evaluation of department personnel (contract and internal) to ensure the efficient operation of the function, and may manage and mentor Ultra Programs staff
  • Participates in the development, review and implementation of departmental SOPs, processes, templates and tools

Requirements:

  • Bachelor’s degree or relevant experience required
  • Experience in rare diseases is a plus, but not required
  • Willingness to address urgent treatment requests when needed
  • 5+ years of relevant industry experience, with at least 3 years of direct clinical trial management experience at a Sponsor/Company or CRO
  • Proven ability to provide functional expertise to a clinical development program in a specified product area with experience in managing CROs, specialty labs, outside vendors and international trials
  • Late Phase or Phase IV experience a plus, but not required
  • Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required
  • Must possess a high degree of customer focus towards internal and external stakeholders; strong collaboration skills, excellent planning skills and able to manage multiple projects with time demands
  • Problem solver and effectively works in a team environment
  • Highly effective verbal and written communication skills required
  • Minimal travel may be required

#LI-CS2
#LI-REMOTE
#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 & 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 [email protected]. 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.
See our Privacy Policy.
 
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[email protected].

More Information on Ultragenyx
Ultragenyx operates in the Biotech industry. The company is located in Novato, CA, Brisbane, CA, South San Francisco, CA, Miami, FL, Cambridge, MA, Waltham, MA, Woburn, MA and Miami, FL. Ultragenyx was founded in 2010. It has 1196 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Dental Benefits, Health Insurance Benefits, Life Insurance, 401(K) and Employee Stock Purchase Plan. To see all 6 open jobs at Ultragenyx, click here.
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