SMA 1

SMA 1

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

About the Role:
We are seeking a highly organized and proactive SMA 1 to support the management and execution of clinical trials. This role involves coordinating trial and site administration, document management, regulatory submissions, budgeting, and meeting planning, ensuring compliance with global and local clinical research standards

Key Responsibilities:

Trial & Site Administration

• Track essential documents and report on safety and other study updates

• Collate and distribute study tools and documents

• Maintain clinical trial databases (CTMS) and trackers

• Manage clinical and non-clinical supplies in coordination with other country roles

• Coordinate labeling requirements and translation requests

Document Management

• Prepare, collate, distribute/ship, and archive clinical documents

• Assist with eTMF reconciliation and quality control

• Update manuals/documents, including patient diaries and instructions

• Prepare Investigator Trial File binders and execute proper destruction of clinical supplies

• Obtain document translations as required

Regulatory & Site Start-Up

• Collect and provide necessary forms/lists for site evaluation, start-up, and submissions

• Track study insurance certificates

• Support preparation of submission packages for IRB/ERC and regulatory agencies

• Publish study results per local legislation where required

Budgeting, Agreements & Payments

• Collaborate with finance/budgeting representatives to develop country/site budgets

• Track and report negotiations, maintain tracking tools

• Develop, negotiate, approve, and maintain contracts (CTRA) in coordination with Legal

• Execute payments to investigators, vendors, and grants

• Monitor compliance with financial procedures and budget closeout

Meeting Planning

• Organize meetings, prepare study memos/letters/protocols

• Support local investigator meetings, including invitations, materials, venue selection, and vendor coordination

Core Competencies

• Fluent in local language and business proficient in English (verbal and written)

• Knowledge of Global, Country/Regional Clinical Research Guidelines

• Hands-on understanding of Good Documentation Practices (GDP)

• Strong IT skills, including MS Office and clinical IT applications; advanced Excel skills required

• ICH-GCP knowledge appropriate to the role

Behavioral Competencies

• Strong time management, organizational, and interpersonal skills

• Effective communication with external customers (sites, investigators)

• High sense of accountability, ability to handle multiple tasks in a changing environment

• Ability to work effectively in a multicultural matrix environment

• Customer-focused, independent, proactive, and solution-oriented

Experience Required:

2–4 years in Clinical Research or relevant healthcare experience
Education: B.A./B.S. in Life Sciences (preferred) or equivalent healthcare experience

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply