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Study Start-Up Manager

hace 2 meses

Madrid, Madrid, España Sin Nombre A tiempo completo

Job Summary

At Sin Nombre, we are seeking a highly skilled Study Start-Up Manager to join our team. As a key member of our EU Center, you will be responsible for managing and coordinating Part 2 packages, ensuring timely submission to regulatory authorities. Your expertise will be crucial in driving the success of our clinical trials.

Key Responsibilities

  • Manage, coordinate, and collate Part 2 packages to ensure timely submission to regulatory authorities.
  • Attend global submission planning kick-off meetings and agree on timeline planning with global and local teams.
  • Ensure local teams are aware of submission timelines to facilitate robust Site Qualification Visits (SQVs) and site selection.
  • Collate Part 2 submission Table of Content (ToC) and corresponding documents completed by local study associate directors.
  • Reach out to countries to ensure ToC reflects country submission documents and meets EU CTR requirements.
  • Check completeness of Part 2 submission packages (downloaded documents) with ToC.
  • Hold EU/EEA local teams accountable for delivery of Part 2 packages to agreed timelines.
  • Provide support to local teams on EU CTR-specific questions and document content.
  • Coordinate Part 2 RFI responses and ensure agreement between local teams and global teams on translations as required.

Requirements

To succeed in this role, you will need:

  • Excellent project management and coordination skills.
  • Strong communication and interpersonal skills.
  • Ability to work in a fast-paced environment and meet deadlines.
  • Knowledge of EU CTR regulations and guidelines.
  • Experience in clinical trials management.