Clinical Trial Manager
hace 1 semana
Ultragenyx Pharmaceutical Inc. is seeking a highly skilled Country Clinical Trial Manager to join our team. As a key member of the Study Management Team, you will be responsible for the day-to-day management of clinical trials in one or several countries.
Key Responsibilities:
- Manage country-specific operational aspects, including CRO/vendor issues and escalation, drug supply management, and oversight of clinical sites.
- Ensure high-quality deliverables are within timelines and budget in the respective country/ies.
- Coordinate and liaise with the Lead Study Manager, CCOL, and CRA to ensure country milestones are delivered for submissions, budgets, and contracts.
- Collaborate closely with the global team to align country timelines for assigned protocols.
- Conduct protocol and site feasibility assessments.
- Develop local language materials, including informed consents and translations.
- Execute and oversee clinical trial country submissions and approvals for assigned protocols.
- Review clinical site documents, contracts, and payments.
- Develop and maintain study timelines and enrolment dashboards for the country.
- Coordinate 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 the 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, oversight of clinical research-related payments, and oversight of financial compliance checks.
- Oversee import activities for clinical trial supplies into the respective country/ies and maintain broker relationships.
- Serve as a liaison and resource for clinical sites.
- Contribute to the maintenance of the Trial Master File.
- Contribute to initiatives and/or special projects, as assigned, adding value to the business.
- Contribute strongly to Global Clinical Operations team knowledge by acting as a process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
Requirements:
- Bachelor's degree or equivalent in a scientific or healthcare discipline.
- At least 6 years of direct work experience in Clinical Research, with international experience from study start-up through closeout 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 Spanish 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.
Ultragenyx Pharmaceutical Inc. 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.
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