My client, a startup based in Galway, is looking to hire a Clinical Affairs Specialist as they expand operations.
The Role
As a Clinical Affairs Specialist, you will support the design, planning, and execution of clinical trials for innovative medical devices. This role involves preparing and submitting clinical investigation applications, liaising with key stakeholders, and ensuring compliance with regulatory requirements.
Responsibilities
* Prepare clinical documentation for submissions to Ethics Committees, Institutional Review Boards (IRBs), and regulatory authorities (e.g., FDA, Competent Authorities).
* Coordinate with external vendors, including CROs, core labs, and biostatisticians.
* Collaborate with study coordinators and investigational sites to manage clinical trial activities.
* Track patient enrolment and oversee data management processes.
* Support regulatory activities related to clinical trials.
* Ensure clinical data is accurately documented and analysed.
* Maintain compliance with SOPs, Good Clinical Practice (GCP) regulations, and other relevant regulatory guidelines.
Requirements
* Bachelor’s degree in Engineering, Life Sciences, or a related field.
* Minimum of 2 years of experience in the medical device or pharmaceutical industry.
* Strong understanding of clinical trial requirements and Good Clinical Practice (GCP). Regulatory experience is a plus.
* Excellent interpersonal and communication skills.
* Strong writing and comprehension skills for preparing clinical documentation.
* Experience working in an SME environment (preferably in a medtech start-up) is desirable.
* Ability to work independently and within a small, dynamic team.
* Hands-on approach with a commitment to continuous learning and professional development.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717
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