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ICON Clinical Research Study Start Up Associate I in Sofia, Bulgaria

Study Start-Up Associate I - Fluent in German and English

Office Based - Hybrid

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Responsibilities:

Perform a variety of routine essential document collection, review, negotiate to ensure successful site activation

Perform recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for project lifecycle

Complete submissions and notifications to regulatory authorities, ethics committees and other bodies

Set up and maintain study documents in application systems e.g. CTMS, TMF System

Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk,

and escalate issues as soon as identified

Investigational Product (IP) release in accordance with regulatory and Sponsor requirements

Establish and maintain effective and proactive communication with Study Sites and internal personnel regarding study status and activation milestone.

You will be fully supported in your role by a dedicated functional manager and benefit from a clear progression pathway!

What you need

German and English Language Fluency

Bachelor’s degree or international equivalent (preferred life-sciences degree or be a licensed healthcare professional)

Good spoken and written communication skills

Strong collaborative and time management skills

Critical thinker and a good eye for detail

Preferred previous experience of working in a CRO or Pharma environment

Good knowledge with office applications and aptitude for learning new software and systems

Proficient project management skills

We are open to candidates who have recently completed training as CRAs, Study Nurse, or Study Coordinator and are eager to grow in their career within our organization

Benefits of Working in ICON:

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

You’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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 to perform the essential functions of a position, please let us know through the form below.

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