Senior Study Start-Up Lead

hace 5 días

Madrid, Madrid, España Caidya A tiempo completo

**Job Overview**

The Senior Study Start-Up Lead will be responsible for managing the global and/or regional submission of clinical trial applications for studies executed by Caidya on behalf of clients. This role requires the ability to independently compile, review, and approve essential study documents, as well as have a solid understanding of regulatory submission requirements for competent authorities and ethics committees/IRBs throughout the regions where Caidya conducts clinical trials.

**Key Responsibilities**

  • Oversee the management of progress of ethics committees/IRB and competent authority submissions made by country experts, requiring technical knowledge of clinical trial conduct, ICH/GCP, and regional/local regulations.
  • Act as a study lead for assigned countries and regions, participating in kick-off meetings, sponsor calls, and providing procedural and legal guidance to clients.
  • Perform risk management to identify potential risks and create mitigation plans, documenting related risks.
  • Prepare and support the forecast of all study milestones and intermediate steps, overseeing execution to achieve contracted milestones.
  • Operationally manage country specialists, ensuring project-related training is completed prior to performing project activities.
  • Manage country specialists to report metrics in real-time into reporting systems, including planned and actual data.
  • Prepare the clinical trial application package, including review of documents such as the application form, protocol, IB, IMPD/Quality, and patient-facing documents.
  • Review and approve country submission dossiers, including queries and amendment management.
  • Inform project teams about amendment approvals for immediate implementation.
  • Accountable for Annual Progress Report submission, End of Trial notification, and Clinical Study Report submission, as applicable.
  • Responsible for the operational performance of the reporting project team, escalating issues to the appropriate line manager.
  • Collaborate with Clinical Contracts to ensure oversight of Clinical Trial Agreements and budget templates for participating sites.

**Requirements**

  • Excellent verbal and written English communication skills, as well as native language communication skills.
  • Strong technical knowledge of clinical trial conduct, ICH/GCP, and regional/local regulations.
  • Ability to work independently and as part of a team.
  • Strong project management and organizational skills.
  • Excellent problem-solving and risk management skills.

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