Reg & Start Up Specialist, US Support, cFSP

Argentina Job Openings

IQVIA

Buenos Aires

FULL TIME

November 13, 2024

Regulatory & Start Up Specialist, c FSP - US Support
Argentina - 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

We regret to inform you that this job opportunity is no longer available as it has expired

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