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Contractor Country Clinical Trial Manager
hace 2 semanas
**Why Join Us?**
- Be a hero for our rare disease patients_
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**:
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 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
