Clinical Trial Site Manager

hace 1 semana


Madrid Centro, Madrid, España Pfizer A tiempo completo
Job Summary

Pfizer is seeking a highly skilled Senior Site Care Manager to join our team. As a key member of our site management organization, you will be responsible for ensuring the successful execution of clinical trials at investigator sites.

Key Responsibilities
  • Site Start-up and Activation
    • Deploy site strategies by qualifying and activating assigned sites
    • Support processes to optimize country and site selection activities
    • Collaborate with key stakeholders to provide country-level input to country outreach surveys
    • Provide country-level input to country strategy, feasibility, and protocol design
  • Study Conduct and Close-out
    • Act as operational point of contact for all site-level questions
    • Review site monitoring reports
    • Support the site with revision and submission of ICD documents
    • Work with other roles to maintain system management at site level
  • Proactive Site Intelligence
    • Provide input into country strategy and planning
    • Provide input to cluster-level intelligence for site strategy
    • Support the development of local requirements for the importation/exportation of investigational medical products
Requirements
  • Education
    • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
  • Experience
    • Demonstrated experience in site management with prior experience as a site monitor
    • Demonstrated experience in start-up activities through to site activation
    • Demonstrated experience in conduct and close-out activities
  • Skills and Technical Competencies
    • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
    • Excellent communication, presentation, and interpersonal skills
    • Ability to manage required travel of up to 75% on a regular basis
Organizational Relationships
  • Direct report to DCSO (or Site Care Partner/FSP Line Manager)
  • Indirect relationships with Global Study Manager, Study Operations Manager, Start-up PM, SAP-CTA, and CTRO

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