Ultragenyx
Biotechnology • Pharmaceuticals
Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.
Country Clinical Trial Manager – Fixed Term Contract
Job not on LinkedIn
November 12
🗣️🇯🇵 Japanese Required
Ultragenyx
Biotechnology • Pharmaceuticals
Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.
📋 Description
• 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
🏖️ Benefits
• 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
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