SMA I

As a SMA I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Propose regulatory strategies and timelines for clinical study applications and amendments to Competent Authorities (CAs) and Ethics Committees (ECs).
• Prepare and adapt country-specific regulatory documents and submission packages in line with local requirements.
• Identify and address regulatory risks and issues, collaborating with internal teams to implement effective solutions.
• Act as the main contact for vendors and subcontractors throughout the study lifecycle for regulatory submissions.
• Lead assigned projects in regulatory submission activities, ensuring alignment with established strategies and deadlines.
• Support and manage the full site contracting process from pre-negotiation planning to site closure, including contract drafting, review, and execution.
• Ensure proper budget structuring, approval, and site-level budget split, and coordinate study-related payments where applicable.
• Take ownership of assigned project tasks, including documentation development, site support, and operational tracking.
• Maintain compliance with regulatory standards and internal procedures, while identifying training and mentoring needs.
• Foster strong collaboration with internal stakeholders, investigators, and site personnel to drive project success.

You are:

• University or college degree required; a background in life sciences or medical studies is preferred.
• Experience in clinical trials, including expreince in Start-Up activities. Basic knowledge of Clinical Operations is essential.
• Strong understanding of ICH-GCP guidelines and applicable EU and local regulatory requirements.
• Advanced knowledge of the clinical trial registration process, contracting principles, and legal terms and conditions.
• Solid awareness of Sponsor organization structure and key operational drivers.
• Proven ability to work independently in a dynamic, fast-paced, high-volume environment.
• Demonstrated capability to manage multiple projects in parallel and deliver on deadlines.
• Strong problem-solving skills with a proactive and creative approach.
• Excellent interpersonal and influencing skills, with outstanding verbal and written communication.
• Advanced planning, analytical, and leadership abilities.
• Experience in mentoring or guiding team members, including the ability to communicate complex concepts clearly.
• Strong team-building and collaboration skills to drive project success.
• Effective presentation skills.
• Fluency in both English and the local office language, written and spoken.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.