Country Clinical Trial Manager- Fixed term contract

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 Country Clinical Trial Manager (CCTM) is part of the Study Management Team (SMT). The CCTM is responsible for the country specific day-to-day management of a clinical trial which may include oversight of clinical monitors and clinical trial sites in one or several countries. The CCTM may also support the Lead Study Manager with tasks that might not be specific to the country/countries. The CCTM is also accountable for ensuring high quality deliverables are within timelines and budget in the respective country/ies.

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 country specific operational aspects, such as CRO/vendor issues and escalation, drug supply management, oversight of clinical sites, etc.
• Manages country deliverables including start up, enrolment and end of study timelines. Responsible for country level quality and compliance with assigned protocols.
• Coordinates and liaises with LSM, CCOL, CRA to ensure country milestones are delivered for submissions, budgets and contracts. Collaborates closely with global team to align country timelines for assigned protocols.
• Conduct protocol and site feasibility assessments
• Develop local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Execute and oversee clinical trial country submissions and approvals for assigned protocols if applicable
• Review clinical site documents (e.g., site specific informed consent forms), contracts, and payments
• Develop and maintain study timelines and enrolment dashboards for country
• Coordinates with CRA and Data Management to ensure timely data entry, resolution of queries and escalation of data related issues.
• Support the study budgeting process for respective country/ies, including the review of clinical trial financial accruals
• Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing,

archiving and retention requirements, and insurance process management. Enter and update country information in clinical systems

• Ownership of country and site budgets. Development, negotiation, and completion of Clinical Trial Research Agreements. Oversee clinical research-related payments. Oversee financial compliance checks.
• Oversee import activities for clinical trial supplies into respective country/ies and maintain broker relationship.
• Serve as a liaison and resource for clinical sites
• Contribute to maintenance of the Trial Master File
• Contribute to initiatives and/or special projects, as assigned, adding value to the business
• Contributes to the development and review of local Standard Operation Procedures.
• Contribute strongly to Global Clinical Operations team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required
• May support the following activities: review site visit reports, provide drug supply assumptions for country/ies to the clinical planning team, training of local CRA, prepare country updates for SMT

Requirements:

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• At least 6 years of direct work experience in Clinical Research, with international experience from study start up through close out preferred
• Previous experience managing the day-to-day operations of clinical trials
• Previous monitoring experience preferred
• 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
• Flexible and solution focused
• 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 in Japanese and English, additional language/s is an asset.
• Knowledge in budget and contract negotiation, submission, and approval process
• Strong customer focus
• 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% travel may be required

#LI-CK1 #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.

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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.