Descripción de la oferta
FIELD CLINICAL SPECIALIST – SpainMEDICAL DEVICES (ICD/EP/CRM)Our client is developing a novel medical device. It is an exciting time for all who work at the company. With promising early-stage results (to be released in 2026), they are now entering into a European wide Clinical study.This is an opportunity to join a rapidly growing Medical Device manufacturer and be part of this unique Device study.You will be the be the 'go to' person and cover the implant solo for the company.Exciting times ahead....what to find out more?KEY ACCOUNTABILITIES:Site Management & Monitoring• Conduct qualification, initiation, routine monitoring, and close-out visits in accordance with the monitoring plan.• Ensure site adherence to the protocol, regulatory requirements, ISO 14155, and SOPs.• Verify informed consent procedures and patient eligibility checks.• Perform source data verification (SDV) and ensure timely resolution of queries.• Provide ongoing training and support to site staff on study procedures, electronic data capture, and device handling.Study Execution & Oversight• Track patient recruitment, site performance metrics, and protocol compliance.• Identify issues, risks, and deviations; collaborate with internal teams to implement corrective actions.• Assist with trial supply management (device accountability, shipping, reconciliation).• Maintain accurate and timely documentation of monitoring activities and site communication.SKILLS/EXPERIENCE REQUIRED:Required:• Bachelor's or Master's degree in Life Sciences, Nursing, Biomedical Engineering, or related field.• 3+ years of medical devices studies.• Strong understanding of ISO 14155, GCP, EU MDR, and applicable national regulations.• Experience conducting routine visits to the sites across multiple EU countries.• Excellent documentation, communication, and problem-solving skills.• Ability to travel across Spain + maybe 1-2 other counties on occasion.• Fluent in English; additional European languages are an advantage.Preferred:• Experience with cardiac or implantable medical devices.• Early feasibility/FIH study experience.
