Clinical Affairs Specialist
Our client, a medical device company, is 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 enrollment and data management.
* Support regulatory activities related to clinicals.
* Ensure clinical data is correctly documented and analyzed.
* 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 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.
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