Clinical Affairs Specialist
We are seeking a Clinical Affairs Specialist to join our Medical Device start-up company and assist with the design, planning, and execution of clinical trials.
Key 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, including 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.
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.
* Excellent writing skills and comprehension skills.
* Experience working in an SME environment is 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 is desirable.
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