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Senior Regulatory & Start up Specialist

Aplica ya
Mapa de ubicación: Bucharest, Romania Full time R1309597

Descripción del trabajo

Join us in our amazing journey!!

Fantastic opportunity to embed yourself in our global clinical operations team working as Regulatory & Start-up Specialist in Romania.

Become an RSU expert managing and performing all tasks at country level associated with Regulatory, Start-Up and Maintenance. Develop your experience working with different sponsors across a multitude of therapy areas and phases.


Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Your responsibilities might include:

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing 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 project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Skills & Requirements:

  • Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
  • +2 years of experience in the submission of applications, modifications and notifications of Clinical Trials to the Health Authorities (AEMPS) and site contract negotiation.
  • Fluency in Romanian & English  
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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!

Are you interested or do you know the ideal candidate?

  • If you know the right candidate please share this job opportunity - for more information on this role please contact joyce.guillen@iqvia.com
  • Please note is necessary that your application is registered in our Talent Network (WorkDay) to process your candidacy

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

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