Clinical Trial Operations Manager

hace 4 semanas


Madrid, Madrid, España Ultragenyx Pharmaceutical A tiempo completo

Be a Hero for Rare Disease Patients

At Ultragenyx Pharmaceutical, we believe that taking impactful action to care for patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that advances our field. 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 meaningful ways.

Our Commitment to Patients and People

We remain 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. If you want to have a meaningful impact, do the best work of your career, and grow professionally and personally, come to an organization where we would be proud for our family, friends, and children to work.

Job 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 are not specific to the country/countries.

Responsibilities

  • Manage country deliverables, including start-up, enrollment, and end-of-study timelines.
  • Ensure country-level quality and compliance with assigned protocols.
  • Coordinate and liaise with the Lead Study Manager, Clinical Coordinating Officer, and Clinical Research Associate 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 local language Informed Consents and translations.
  • May interact with Institutional Review Boards (IRBs) and Regulatory Authorities for assigned protocols.
  • Execute and oversee clinical trial country submissions and approvals for assigned protocols if applicable.
  • Review clinical site documents.

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