Senior Site Manager
hace 7 días
**Job Summary**
Reconocida Empresa is seeking a highly skilled and experienced Senior Site Manager to join our Clinical Trials team. As a Senior Site Manager, you will be responsible for managing clinical trials at assigned sites, ensuring compliance with internal SOPs, procedural documents, and policies.
**Key Responsibilities**
- Participate in site assessments and conduct pre-trial site assessment visits to provide recommendations on site/investigator selection.
- Act as primary contact for assigned sites and work closely with the trial team to ensure study progress and issue resolution.
- Attend investigator meetings as needed and execute activities within site initiation and start-up, site monitoring, site management, and site/study close-out.
- Implement the Analytical Risk-Based Monitoring (ARBM) model at the site level when applicable.
- Monitor study progress at site using study-specific systems and available reports/dashboards.
- Ensure site staff have current GCP and necessary protocol, compound, and systems training to conduct the clinical trial.
- Contribute to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
- Ensure site study supplies are adequate for trial conduct and collaborate with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS) to ensure clinical drug supplies are handled, administered, and stored properly.
- Ensure accuracy, validity, and completeness of data collected at trial sites and maintain complete, accurate, and timely data and essential documents in systems utilized for trial management.
**Requirements**
- Strong knowledge of clinical trials operations and management.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Ability to maintain confidentiality and handle sensitive information.
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