Clinical Trial Site Manager
hace 1 semana
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
- 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
- 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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