Medical Data Specialist

2 days left

Blue Pelican
23 Jul 2019
19 Aug 2019
Contract Type
Full Time
Medical Data Specialist (Clinical Data Management)
12 Month Fixed Term Contract
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 Medical Data Specialist (Real World Data Specialist) to join their Expanded Access Programmes team.
Working within a specialist Expanded/Managed Access team, you will be providing medical operations support for clients who are using the teams expertise of running Expanded Access Programmed around the world. As a Medical Data Specialist, you will be supporting clients with designing protocols, amending SOP's, monitoring sites, and ensuring the collection of patient data.
  • 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 support the setting up of 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 treatment guidance and collecting 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)
??Experience of designing and 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