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Regulatory & Start Up Specialist, cFSP - US Support

Mexico - Full Home Based role

Purpose:

The RSU Specialist 1 proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country: US.

Responsibilities

Primary responsibilities include but are not limited to:

• Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites
• Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
• Proactively identifying and communicating issues impacting delivery and providing proposed solutions
• Attending regional/area start up calls and providing input for assigned sites/studies
• Collection of essential documents from sites and completing quality check (ALCOA)
• Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
• Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements

Qualifications:

• Bachelor's Degree required, degree in health care or scientific field preferred
• A minimum of 1-2 years of clinical research experience and +1 year of study start up management experience supporting US.
• Advanced English level
• Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives
• Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements
• Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment  

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com