My client who are a growing Medical Device start-up company are seeking a Clinical Affairs Specialist to join their team and assist with the design, planning and execution of clinical trials.
As part of the role, you will also prepare and submit applications for clinical investigations.
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 such as 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.
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 A hands-on mindset At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.
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Clinical Affairs Clinical Trials Medical Device Regulatory