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Real World Clinical Data Specialist - CRF Design

If you have clinical data and clinical trial operations experience, we would like to hear from you. An expanding clinical services company are looking for a Clinical Data Specialist to join their Expanded Access Programmes team.

Working within a specialist Expanded/Managed Access team, you will be providing medical data capturing advice and support to clients who are using the teams expertise of running Expanded Access Programmed around the world. As a Clinical Data Specialist, you will be supporting clients with designing CRF's, amending SOP’s, and ensuring the collection and completeness of patient data.

Responsibilities:

  • You will be involved in Expanded Access Programmes from the design and start-up phase through to close out/programme shut down.
  • During the start-up of an Expanded Access Programme, you will work with the Programme lead to develop and implement treatment protocols and other necessary medical documents.
  • You will also be working closely with sponsors to design CRF's, that accurately collect essential data. You will also work with the client and wider team to set up data capture tools and processes for new programmes.
  • During the course of a programme’s operation, you will ensure treatment protocols and data capture tools are available to physicians and all other necessary health care professionals.
  • You will act as a point of contact for all questions that come from health care professionals, regarding the capturing of data.
  • During the course of the programme, you will ensure all real-world data is collected and collated, ensuring the data’s completeness.
  • Prepare status reports during the course of the programme, including interim reports on the data collected and reports required by regulatory agencies.
  • Speedily provide/forward Adverse Event findings to the relevant pharmacovigilance team or responsible person.
  • On close out of the programme, you will ensure all data is collected and ensure all programme reports are drafted and shared with clients.

Required qualifications, experience and skills includes:

  • You will have a Science-based degree
  • Have experience of operating in clinical operations or clinical trials (preferably site monitoring, data management and report writing)
  • You will have experience of designing/writing CRF's
  • Experience of designing or amending protocols and SOP’s
  • You will have experience of working with third parties and can build relationships with key internal and external stakeholders
  • Proven experience with clinical data management tools

This role will initially be for a 12 Month Fixed Term Contract. After this point, there is a possibility of the position converting into a permanent position.