RSU Specialist I, FSP Sponsor Dedicated (Home Based)

About the role

iQVIA is hiring an RSU Specialist I (Regulatory & Start Up Specialist 1, cFSP) for a full home-based role in Mexico City. The specialist proactively drives and executes start-up and maintenance activities and deliverables for assigned studies and sites within their assigned country.

Key responsibilities

• Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Managers, the Project Management team and other departments under general supervision, ensuring adherence to SOPs, work instructions, deliverable quality and project timelines.
• Perform start-up and site activation activities according to regulations, SOPs and work instructions, and distribute completed documents to sites and the internal project team.
• Prepare site regulatory documents and review them for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project-specific information, and review and give feedback to management on site performance metrics.
• Review, establish and agree on project planning and timelines, ensure monitoring measures are in place and implement contingency plans as needed.
• Track and follow up the progress, approval and execution of regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents, and inform team members when regulatory and contractual documents are complete.
• Provide local expertise to Site Activation Managers and the project team during planning, perform quality control of site documents, and may have direct contact with sponsors on specific initiatives.

Required profile

• Bachelor's degree in life sciences.
• At least 1 year of clinical research experience and study start-up management experience.
• Fluent English, written and spoken.
• Good analytical and critical thinking skills, and the ability to evaluate complex issues from multiple perspectives.
• Good interpersonal skills, able to build trust and adapt to changing requirements.
• Demonstrated successful execution, preferably in start-up, and aptitude for managing multiple priorities in a fast-paced environment.