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Medical Device Clinical Specialist
2 weeks ago
Clinical Affairs Specialist
We are currently recruiting for a permanent role in the field of clinical affairs at Life Science Recruitment Ltd.
This position involves assisting with the design, planning and execution of clinical trials. You will also prepare and submit applications for clinical investigations. This role offers hybrid working opportunities.
Key Responsibilities:
- Prepare clinical documents for submission to ethics committees, institutional review boards and regulatory 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 and 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.
