Clinical Affairs Specialist
Our growing Medical Device start-up company is seeking a highly skilled Clinical Affairs Specialist to assist with the design, planning and execution of clinical trials. Key responsibilities include preparing and submitting applications for clinical investigations.
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.
• Collaborate 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.
• 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 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.
What We Offer:
As a leading recruitment agency, we provide our clients with exceptional professionals who can drive their businesses forward. Our expertise lies in sourcing top talent for key industries and services. If you are passionate about your work and want to join a dynamic team, please contact us.