Clinical Trial Subject Matter Expert (CT SME)

About the role

Firecrest Clinical, part of the ICON plc Group, creates highly visual and engaging training products for the clinical trial industry. As a clinical training provider for medical staff, the Clinical Trial Advisor role is central to delivering accurate, high-quality training to clients. The Clinical Trial SME uses clinical research experience to help colleagues produce accurate and engaging content, working independently or with the team to deliver digital solutions that meet sponsors' needs and timelines.

Key responsibilities

• Use clinical research experience to help colleagues produce accurate and engaging content for stakeholders.
• Create high-quality digital solutions in line with sponsor needs, expectations and delivery timelines.
• Advise and support the production team (Instructional Designer, Graphic Designer, Product Testing Analysts) on clinical trial matters across therapeutic areas.
• Ensure technical accuracy of products and that clinical content adds value for sponsors, site staff, investigators and patients.
• Review study documentation provided by the sponsor and attend sponsor meetings, assisting the Project Manager as needed.
• Escalate protocol-related queries to the Project Manager or In Team Lead.
• Maintain knowledge of ICH/GCP guidelines, regulations and company SOPs, completing assigned training.
• Assist in training and mentoring less experienced CT SMEs, depending on experience level.
• Identify operational efficiencies and process improvements, and take on additional responsibilities as directed by management.

Required profile

• B.Sc. (Hons) in life sciences or equivalent.
• Minimum 2-3 years of experience as a CRA, site coordinator or study nurse in clinical research.
• Experience across different trial phases and therapeutic areas.
• Excellent written and verbal communication in English.
• Legal right to work in the country where the role is based.

Required skills

• Knowledge of ICH GCP guidelines and experience reviewing study documentation.
• Practical knowledge of clinical trials and experience with different clinical trial systems and vendors.
• Analytical skills, attention to detail and ability to work independently and in a project team.
• Ability to produce accurate work within tight deadlines.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.