Study Start-Up Specialist

Study Start -Up Specialist - Romania - Hybrid

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

We are currently seeking an experienced Regulatory/ Submission Specialist/Study Start-Up Specialist to join our diverse and dynamic FSP team.

In this role you will be responsible for managing and overseeing the process of Clinical Trial Applications for all trials in Romania, from first submission to approval, including managing and submission of amendments.

What you will be doing

• Perform quality review of country and site level essential documents following a risk-based approach,issue queries, and communicate outcome to identified users at key milestones and during the course of the study
• Ensure that preparation and submission of Clinical Trial Applications, amendments and related documents are in compliance with EU CTR including follow-ups and RFIs and are available in time for submission
• Oversee day-to-day delivery of all aspects of site activation in assigned projects, ensuring adherence to sponsor timelines, expectations, and compliance with ICON/client KPIs, SOPs, and regulatory standards.
• Translation, review and adaptation of local documents in local language
• Preparation, tracking, and distribution of site start up documentation including Investigator Site File
• Manage oversight, in collaboration with Local CTM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
• Provide input on site activation strategy
• Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva Vault

Your profile

• Bachelor's Degree, preferably in life sciences.
• Previous experience and knowledge in management of Clinical Trial Applications as per EU Clinical Trials Regulations, and in regulatory legislation and processes (Romania and EU) relating to clinical trials
• Strong project management skills, with a deep understanding of regulatory and submission processes in various countries.
• Excellent written and verbal communication abilities.
• Proven ability to work efficiently to tight deadlines and manage multiple priorities.

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, 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 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

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.