Senior Clinical Trials Coordinator 356

In the context of a brand new project, we are looking for a consultant to join us asap on the following exiting missions:

About us

Group 10
Responsibilities

  • Responsible for overall planning and execution of regulatory and ethics submissions for assigned projects/countries (all regions especially Europe)/sites, which may include completion of submissions or notifications, as required. 
  • Direct and oversee short-term and long-term planning of regulatory submission initiatives. 
  • Develop and implement strategies for the earliest possible approval of regulatory submission. 
  • Responsible for review, compilation and submission of the CTA dossier through the CTIS portal for Europe or another applicable regulatory portal 
  • Responsible for providing strategic advice and support to the project team for regulatory aspects of the clinical trials and late phase studies 
  • Responsible for collaborating with Regulatory Affairs Core Teams and the Regulatory Affairs Clinical Studies Actors and other cross-functional teams. 
  • Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form. 
  • Prepare responses to inquiries / comments from regulatory authorities on the CTA dossier or related documents. 
  • Maintaining and monitoring an up-to-date knowledge of the European and other applicable regulatory requirements and processes. 
  • Participate in internal working groups (SOP management group) and external working groups (EFPIA etc) on scientific and regulatory subjects. 

 

Group 12
Experience

  • Education: Master in the pharmaceutical / scientific field 
  • Strong knowledge of ICH/GCP guidelines or other relevant guidelines 
  • Good understanding of Clinical trial regulation and the Clinical trial information system
  • Ideally EU / Global experience 
  • Proficiency with computer systems
  • Strong verbal and written communication skills 
  • Strong organizational, time management, interpersonal skills 
  • Ability to work both independently and in a team environment

 

 

Clinical Trials Coordinator 356