Senior Site Manager

hace 7 días


Madrid Centro, Madrid, España Reconocida empresa A tiempo completo
Job Summary

We are seeking a highly skilled and experienced Senior Site Manager to join our team at Reconocida empresa. As a Senior Site Manager, you will be responsible for managing clinical trials at our sites, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve project goals.

Key Responsibilities
  1. Site Management: Manage clinical trials at our sites, including site initiation, monitoring, and close-out.
  2. Regulatory Compliance: Ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) and applicable regulations.
  3. Collaboration and Communication: Collaborate with cross-functional teams, including clinical research coordinators, investigators, and other site staff, to ensure smooth trial execution.
  4. Training and Development: Ensure site staff have current GCP and necessary protocol, compound, and systems training to conduct the clinical trial.
  5. Recruitment and Contingency Planning: Contribute to site-level recruitment strategy and contingency planning to achieve clinical research targets.
  6. Supply Management: Ensure site study supplies are adequate for trial conduct.
  7. Investigational Product Management: Ensure clinical drug supplies are appropriately handled, administered, and stored, and that strict adherence to investigational product preparation and administration guidelines is maintained.
  8. Data Management: Ensure accuracy, validity, and completeness of data collected at trial sites, and that appropriate measures are in place for maintenance of the blind when applicable.
  9. Reporting and Documentation: Ensure timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC), and documentation of trial-related activities.
  10. Quality Assurance: Collaborate with Quality Assurance (QA) to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or inspection and for quality issues identified at the site.
  11. Close-Out and Archiving: Prepare trial sites for close-out, conduct final close-out visit, and ensure archiving retention requirements are met.
  12. Lessons Learned and Process Improvement: Coordinate site-level lessons learned activities and contribute to process improvement and training as needed.
Requirements
  • Experience in clinical research, preferably in a site management role.
  • Strong knowledge of GCP and applicable regulations.
  • Excellent communication and collaboration skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Ability to adapt to changing priorities and deadlines.


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