Site Manager

hace 7 días

Madrid, Madrid, España Importante empresa A tiempo completo
Job Summary

We are seeking a highly skilled Site Manager to join our team at Importante empresa. As a Site Manager, you will be responsible for ensuring the smooth execution of clinical trials at assigned sites, ensuring compliance with regulatory requirements and company SOPs.

Key Responsibilities
  1. Act as the primary local contact for assigned sites, ensuring effective communication and collaboration with site staff and other stakeholders.
  2. Participate in site feasibility and pre-trial site assessment visits to ensure site readiness and compliance.
  3. Attend investigator meetings and provide support to site staff as needed.
  4. Execute site initiation and start-up activities, including preparation and conduct of site monitoring, site management, and site close-out.
  5. Ensure site staff are trained and trained records are complete and accurate.
  6. Collaborate with the Local Trial Manager and central study team to activate sites in the shortest possible timeframe.
  7. Contribute to site-level recruitment strategy and contingency planning.
  8. Ensure site study supplies are adequate for trial conduct.
  9. Ensure clinical drug supplies are properly used, handled, and stored, and returns are accurately inventoried and documented.
  10. Arrange for the destruction of clinical supplies.
  11. Ensure site staff complete data entry and resolve queries within expected timelines.
  12. Ensure accuracy, validity, and completeness of data collected at trial sites.
  13. Report Adverse Events, Serious Adverse Events, and Product Quality Complaints within required timelines.
  14. Maintain complete, accurate, and timely data and essential documents in relevant systems.
  15. Document trial-related activities, particularly monitoring.
  16. Review study files for completeness and ensure archiving retention requirements are met.
  17. Collaborate with the Local Trial Manager to document and communicate site/study progress and issues to the trial central team.
  18. Attend regularly scheduled team meetings and trainings.
  19. Comply with relevant training requirements.
  20. Work closely with the Local Trial Manager to ensure Corrective Action Preventative Action is completed for Quality Assurance site audits and quality issues identified at the site.
  21. Prepare trial sites for close-out and conduct final close-out visits.
  22. Track costs at site level and ensure payments are made, if applicable.
  23. Establish and maintain good working relationships with internal and external stakeholders, particularly investigators, trial coordinators, and other site staff.
  24. Participate in Health Authority and IEC/IRB submission and notification processes as required.
  25. Act as a point of contact for site management practices.
  26. May be assigned as a coach and mentor to a less experienced site manager.
  27. May contribute to process improvement and training.
  28. Lead and/or participate in special initiatives as assigned.
Qualifications

A minimum of a BA or BS degree in Life Sciences, Nursing, or a related scientific field (or equivalent experience) is required. A minimum of 2 years of clinical trial monitoring experience is preferred. Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols, and associated protocol-specific procedures, including monitoring guidelines. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stays away from home. Proficient in speaking and writing the country language and English. Good written and oral communication skills.

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