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Site Manager
hace 2 meses
**Job Summary**
Johnson & Johnson is seeking a highly skilled Site Manager to join our Early Development & Clinical Pharmacology team. As a Site Manager, you will be responsible for ensuring the successful conduct of clinical trials at assigned sites, ensuring compliance with regulatory requirements and company standards.
**Key Responsibilities**
- Participate in site assessments, conduct pre-trial site assessment visits, and provide recommendations on site/investigator selection in collaboration with the trial team.
- Act as primary contact for assigned sites for specific ED&CP trials and work closely with the Trial Manager and trial central team regarding study progress and issue resolution.
- Attend/participate in investigator meetings as needed.
- Execute activities within site initiation and start-up, site monitoring, site management, and site/study close-out per internal SOPs, other procedural documents, and policies.
- 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.
- In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensure that clinical drug supplies are appropriately handled, administered, and stored.
- Ensure site staff complete the data entry and resolve queries within expected timelines.
**Requirements**
- Strong understanding of clinical research operations and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
