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Regulatory & Start Up Specialist - SPAIN

Aplica ya
Mapa de ubicación: Madrid, Madrid, Spain Full time R1212627

Descripción del trabajo

Join us in our exciting journey!!

A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world. 

With a fantastic work/life balance, this is a great opportunity for a Regulatory & Start-up Specialist willing to to discover how a true partnership between different parties works!

The role

  • Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level.

  • Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of regulatory and contractual documents for sites; ensures contracts are fully executed; and establishes project timelines.

Responsabilities

  • Set up and maintain DrugDev Spark for new projects (i.e. checklists, dashboards, reports, and document templates

  • Negotiate simple contractual documents with investigator sites (i.e. CDAs) as determined by the Start-Up Lead or Senior Start-Up Lead

  • Lead site feasibility projects which includes feasibility questionnaire distribution and collection, as well as leading project team meetings with clients

  • Perform quality control reviews of Essential Site Regulatory Documents via DrugDev Spark

  • Upload investigator site documents to client specified locations (i.e. client e-TMF, SharePoint workspace, etc…)

  • Serve as primary point of contact for investigator sites, either personally or through a shared mailbox.

  • Assist in the preparation for regulatory and/or sponsor audits

What we offer:

  • Focus on quality, not quantity! We invest in keeping our teams stable, so workload is consistent

  • The chance to work on cutting edge medicines right at the forefront of drug development

  • Genuine career development opportunities for those who want to grow as part of the organization

  • Excellent salary and benefits package

  • Flexible working hours

We invite you to join IQVIA™

  • Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)

  • FORTUNE Magazine's World's Most Admired Companies list for the fourth year in a row (January 2021)

  • Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)

  • Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.

  • A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.

  • IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

IQVIA™ is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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