Clinical Trial SME

In brief

**Overview** This role is for a Clinical Trial SME (Subject Matter Expert) within Firecrest Clinical, which is part of the ICON plc Group. Firecrest Clinical specializes in developing highly visual and engaging products for the Clinical Trial Industry, aiming to improve site performance by delivering innovative and effective training while complying with Industry Standards. As an organization focused on clinical training for medical staff, the Clinical Trial Advisor (SME) position is critical for ensuring the delivery of accurate and high-quality training products to clients. **What you will do** * Uses clinical research experience, accrued from previous clinical research roles, to assist colleagues in the production of accurate and engaging components for our stakeholders. * Works actively, independently or with the team depending on the task, to create the high quality digital solutions in line with the sponsor's needs and expectations, and within sponsor delivery timelines. * Advises and supports the production team (Instructional Designer, Graphic Designer, Product Testing Analysts) on clinical trial related matters, across therapeutic areas. * Ensures technical accuracy of the products/solutions at each stage of the product development, while ensuring the clinical content adds maximum value for end users (Sponsors, Site Staff, Investigators, and Patients). * Conducts comprehensive review of study documentation provided by the sponsor. * Attends sponsor meetings and assists Project Manager (PM) as required to support product development. * Communicates/escalates protocol-related queries to the Project Manager (PM)/In Team Lead (ITL). * Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. * Assumes additional responsibilities as directed by CTSME Supervisor and/or other management. * Identifies operational efficiencies and process improvements, contributing to an environment of continuous learning and improvement. * Depending on level of experience, assists in training and mentoring of less experienced CT SMEs. * Ensure the maintenance of a high personal level of knowledge concerning current regulation and changes within the clinical research industry by means of internal support and individual learning. **Requirements (from the original advert)** * B.Sc. Hons in life science or equivalent. * Minimum 2-3 years' experience as a CRA/site coordinator/study nurse within the clinical research industry. * Experience across different trial phases and therapeutic areas. * Excellent practical knowledge and understanding of the complexity of clinical trials and experience with different clinical trial systems/vendors. * Excellent analytical skills and attention to detail. * Ability to work independently as well as part of the project team, depending on the solution requirements. * Ability to produce accurate work within tight deadlines. * Knowledge of ICH GCP guidelines and experience in reviewing study-related documentation. * Excellent written and verbal communication in English. **Who should apply** This role is suitable for individuals with a B.Sc. Hons in life science or an equivalent qualification, coupled with a minimum of 2-3 years' experience in the clinical research industry as a CRA, site coordinator, or study nurse. The ideal candidate will have experience across various trial phases and therapeutic areas, demonstrating excellent practical knowledge and understanding of clinical trial complexities, including familiarity with different clinical trial systems and vendors. Applicants should possess strong analytical skills, attention to detail, and the ability to work both independently and collaboratively within a project team to produce accurate work under tight deadlines. Essential qualifications include knowledge of ICH GCP guidelines, experience in reviewing study-related documentation, and excellent written and verbal communication skills in English. **Deadline** Not specified **Reference** Original posting: https://www.myjobmag.co.za/job/clinical-trial-sme-icon-plc Source: myjobmag

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At a glance

• At least 2 years of experience.

• Google Cloud
• PLC programming

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