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Senior Site Activation Coordinator Romania

IQVIA

IQVIA

Bucharest, Romania
Posted on Oct 15, 2024

Join us in our amazing journey!!

Fantastic opportunity to embed yourself in our global clinical operations team working as Site Activation Specialist, Contract & Budget negotiation in Romania (Legal Background). Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs.

Your responsibilities might include:

  • Preparation and negotiation of contracts, annexes and budgets for conducting a clinical trial.
  • Cooperation (good communication skills) with research teams as well as centers and researchers in the field of contract negotiations, legal education would be an advantage.
  • Additional attributes: meticulousness, accuracy, regularity..
  • Ensures the successful negotiation and on-going management of clinical trial agreements (CTA) with investigative sites and investigators.
  • Works cross functionally with Clinical and RSU Team in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
  • Reviews and negotiates budgets for CTA based on the calculation provided by the Sponsor.
  • Communicates and explains legal/ budgetary issues to internal and external parties per project guidelines.
  • Prepares and concludes amendments to CTA based on client requested contract changes and based upon study CTA guidelines.
  • Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; correct documents and files changes to contracts (QC process).
  • Participates in project’s weekly meetings for the purpose of expediting the contract signing process as directed.
  • Creates and maintains files for each contract.
  • Periodic archiving of contracts for completed projects.

Skills & Requirements:

  • We are looking for one year experience professional with Legal background and potential negotiation skills since our position implies a lot of negotiations with doctors and local vendors.
  • Bachelor degree in Law
  • Fluency in Romanian & English .
  • 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.
  • LOCATION: #Hybrid model (Bucharest)

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!

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 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