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Sinead Cullen
Life Science

01 507 9252
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Details

Clinical Affairs Specialist


Reference:SCA014502 Location: Galway
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Data Manager, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse

Clinical Affairs Specialist
Our client, a medical device company, are currently recruiting for a Clinical Affairs Specialist on a permanent basis. As Clinical Affairs Specialist you will assist with the design, planning and execution of clinical trials. You will also prepare and submit applications for clinical investigations. This role offers hybrid working.

Responsibilities

  • Prepare clinical documents for submission to Ethics Committees, Institutional Review Boards and regulatory authorities such as the FDA and Competent Authorities
  • Liaise with external vendors such as CROs, core labs, and biostatisticians
  • Liaise with study coordinators and investigational site personnel to coordinate clinical trial activities
  • Assist with tracking patient enrolment and data management
  • Support regulatory activities related to clinicals
  • Ensure clinical data is correctly documented and analysed
  • Adhere to SOPs, Good Clinical Practice regulations, and other relevant regulatory requirements
Requirements
  • Degree in Engineering or Science discipline
  • Minimum of 2 years’ experience in the medical device or pharmaceutical industry
  • Understanding of clinical trial requirements and Good Clinical Practice. Regulatory experience is an advantage.
  • Excellent interpersonal & communication skills essential
  • Excellent writing skills and comprehension skills
  • Experience working in an SME environment desirable, preferably in a medtech start-up
  • Commit to ongoing personal development to improve technical and non-technical skillsets
  • Experience in preparation of clinical trial documentation desirable
For more information, please contact Sinéad Cullen on +353879500821