Clinical Affairs Specialist
We are seeking a skilled Clinical Affairs Specialist to join our team at {company}. As a key member of our clinical affairs department, you will play a crucial role in the design, planning, and execution of clinical trials.
Your primary responsibilities will include:
* Preparing clinical documents for submission to ethics committees, institutional review boards, and regulatory authorities such as the FDA and competent authorities.
* Liaising with external vendors, including CROs, core labs, and biostatisticians.
* Coordinating clinical trial activities with study coordinators and investigational site personnel.
* Assisting with tracking patient enrollment and data management.
* Supporting regulatory activities related to clinicals.
* Ensuring clinical data is correctly documented and analyzed.
* Adhering 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.