Description
As a SMA II at ICON, you will support the management and monitoring of clinical trial sites by ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
You will contribute to clinical research activities, taking ownership of key CTA deliverables while collaborating closely with cross-functional teams.
Key responsibilities include:
- Providing advanced administrative and operational support to clinical trial teams across study start-up, maintenance, and close-out activities.
- Managing and maintaining Trial Master File (TMF) documentation, ensuring completeness, accuracy, and inspection readiness in compliance with GCP and regulatory requirements.
- Supporting site activation activities, including collection, review, and tracking of essential regulatory documents.
- Acting as a key point of contact for internal stakeholders, sites, and vendors to ensure effective communication and coordination throughout the study lifecycle.
- Tracking study progress, site metrics, and deliverables, proactively identifying risks or delays and supporting resolution.
- Coordinating study-related logistics such as investigator payments, supplies, and document workflows.
- Assisting with audit and inspection readiness activities, ensuring documentation is complete and compliant.
- Supporting contract and budget tracking activities in collaboration with relevant teams.
- Mentoring or providing guidance to junior CTAs or administrative staff, as applicable.
You will bring solid clinical research experience with a strong focus on clinical trial administration, along with the following qualifications and skills:
- Bachelor’s degree in Life Sciences, Healthcare Administration, Clinical Research, or a related field.
- 2+ years of experience in clinical research, with strong exposure to CTA responsibilities and TMF management.
- Experience supporting global clinical trials and collaborating with cross-functional teams across multiple countries and regions.
- Solid understanding of clinical trial processes, including study start-up, regulatory documentation, and site support activities.
- Strong knowledge of GCP guidelines and applicable regulatory requirements.
- Excellent organisational and time management skills, with the ability to manage multiple priorities in a fast-paced environment.
- High attention to detail and strong documentation skills.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
- Proactive mindset with strong problem-solving and risk identification capabilities.
- Experience with clinical systems (e.g., eTMF, CTMS) and Microsoft Office tools is preferred.
This role is office-based during the first four months to support onboarding, training, and team integration. Following the initial onboarding period, the role will transition to a hybrid work model, with 3 days in the office and 2 days working from home each week.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:
- 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