Clinical Study Administrator

Clinical Study Administrator - Hybrid - Bucharest, Romania

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 recruiting for an experienced Clinical Study Administrator in Romania to work in a sponsor dedicated role for a global biopharmaceutical company.

In this role you will assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

What you will be doing:

• Assists in coordination and administration of clinical studies from the start-up to execution and closeout

• Collects, assists in preparation, reviews and tracks documents for the application process.

• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study

• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents

Serves as local administrative main contact and works closely with the CRAs and/or the Study Managers for the duration of the study

• Set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements

• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.

• Liaises with internal and external vendors

• Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.

Your profile

• Bachelor's degree in a scientific or healthcare-related field.

• Ability to work 3 days per week from the sponsor's office

• Previous administrative experience in clinical research such as: eTMF/ISF/Veeva Vault documentation management, support with submissions documents preparation/collection, payments processing and calculation, etc

• Proven organizational and administrative skills.

• Computer proficiency

• Good knowledge of spoken and written English and Romanian.

• Ability to work collaboratively in a fast-paced environment with attention to detail.

#LI-DS1

#LI-Hybrid

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