Study Start Up Associate / Regulatory Submissions

Study Start Up Associate / Regulatory Submissions ( Georgia - Tbilisi )

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.

Study Start Up Associate II
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

The Role

- 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

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

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. Our annual bonuses reflect delivery of performance goals – both ours and yours.
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.
But beyond the competitive salaries and comprehensive benefits, 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 in order to perform the essential functions of a position, please let us know through the form below.

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