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Site Management Associate
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Job Summary
As a Site Management Associate at 520 Icr Mexico - Mex, you will be responsible for managing, implementing, and monitoring clinical studies within a global organization. This role involves working in a team setting to ensure the successful execution of clinical trials.
Key Responsibilities
- Complete essential document collection and review throughout the study lifecycle, including site activation.
- Manage the electronic Trial Master File for each site, performing periodic QCs and site level maintenance of the eTMF.
- Update Clinical Management Systems, local regulatory tasks, protocol amendments, submissions packages, preparations for sites/ethics committees submissions.
- Conduct remote site monitoring visits and/or targeted on-site visits as needed.
- Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks.
- Perform study tracking CTMS.
- Act as primary site contact/liaison for study and site management issues, including addressing questions, managing study supplies, and conducting offsite central monitoring visits and contacts.
- Escalate issues and risks as needed.
- Provide training and mentoring to less experienced team members.
- Act or assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management, and evaluation of metrics to identify process improvements.
- Contribute to business development activities by participating in proposals and bid defenses.
- Support manager and interface with partner departments to support enhanced project delivery.
- May create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.
Requirements
This role requires a strong understanding of clinical trials and site management processes. The ideal candidate will have excellent communication and organizational skills, with the ability to work effectively in a team environment.