Senior Clinical RA officer

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

About us

Group 10
Responsabilities

  • Assistant to draft and update key documents
  • Detect opportunities for improvement
  • Answers to Competente Authorities administrative questions, in order they can be finalized within expected timelines.
  • In charge of following the update of the whole Product Information for the Reference Summary of Product Characteristics for
  • Investigational Medicial Products/ Auxilliary Medicinal Product(s)initially identified, by preparing summary comparative tables for Product
  • Informations and submitting an impact assessment for validation.
  • Notification to the ANSM of New Event/Urgent Safety Measure
  • Regulatory surveillance for CTs on World Health Organization database
  • Participates in the preparation of any inspection relating to a CT in which you are involved
  • In charge of training the employees to European CT Regulation
  • To ensure execution and delivery of the study as defined by the protocol and according to agreed timelines, quality standards and CT budget
  • To oversee and steer the conduct of the CT from the early preparation until the final CT closure (i.e. from CTsynopsis to CTarchiving)
  • To identify and anticipate any deviations on CT deliverables and put in place action plans to minimize impacts
  • To provide adequate reporting to the Core Team
  • To define the optimal operational strategy
  • To provide technical and practical regulatory input/expertise regarding protocol and amendments writing
  • To coordinate IMPD volumes and other regulatory documents availability (Cover letter, EudraCT…)To coordinate answers to CAs’ questions by expert of each topic, and to make them available to the Study Team
  • To oversee the submissions to regulatory authorities

Group 12
Profile

  • Education : Life science degree, pharmacist education is a plus
  • 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 (around 5/8 Years)
  • Proficiency with computer systems
  • Strong verbal and written communication skills in English, any other language is a plus
  • Strong organizational, time management, interpersonal skills.
  • Team player spirit
  • Ability to work both independently and in a team environment

 

Senior Clinical RA officer