Regulatory & Start Up Specialist I - Central Hub

hace 4 días

Desde casa, México IQVIA A tiempo completo

**Job Overview**

Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities.

**Essential Functions**:

- Serve as Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other departments. Ensure adherence to SOPs, Work Instructions (WIs), quality standards, and project timelines.
- Conduct start-up and site activation activities in line with applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare and review site regulatory documents for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish, and agree on project planning and timelines. Implement monitoring measures and contingency plans as needed.
- Inform team members about the completion of regulatory and contractual documents for individual sites.
- Review, track, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

**Qualifications**:

- Degree in Life Sciences.
- At least 2 years of clinical research experience, with at least 1 year in Regulatory & Start-Up.
- Advanced level of English.

LI-Remote

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