Remote Contractor Clinical Trial Manager

Summary

Join our team at Ultragenyx and be a hero for rare disease patients. We're looking for a Country Clinical Trial Manager to lead the day-to-day management of clinical trials in one or several countries. As a key member of the Study Management Team, you'll oversee country-specific deliverables, manage CRO/vendor issues, and ensure high-quality results within timelines and budget.

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 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 of local regulations and laws related to clinical trials

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

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