Study Start Up Associate / Regulatory Submissions
- Tbilisi
- Study Start Up
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
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.
#LI-remote #LI-AC1
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Teaser label
Inside ICONContent type
BlogsPublish date
11/24/2022
Summary
Life sciences are undeniably an exciting area to start and pursue a career in. In fact, the global life sciences space is predicted to be worth a massive $2 trillion in gross value by 2023. Contra
Who we are
Similar jobs at ICON
Salary
Location
Serbia, Belgrade
Location
Belgrade
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
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 I
Reference
JR120344
Expiry date
01/01/0001
Author
Jaziara HancoxAuthor
Jaziara HancoxSalary
Location
Korea, Seoul
Location
Seoul
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
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 I
Reference
JR118214
Expiry date
01/01/0001
Author
Jennifer KimAuthor
Jennifer KimSalary
Location
Bulgaria, Sofia
Location
Sofia
Prague
Budapest
Bratislava
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate IIAt 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
Reference
JR119033
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Malaysia
Department
Study Start Up
Location
Malaysia
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
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 I
Reference
2024-111215
Expiry date
01/01/0001
Author
Maria ClareAuthor
Maria ClareSalary
Location
Mexico, Mexico City
Location
Mexico City
Business Area
ICON Full Service & Corporate Support
Job Categories
Feasibility
Patient Recruitment
Job Type
Contractor
Description
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 I
Reference
JR121409
Expiry date
01/01/0001
Author
Olivia MolinaAuthor
Olivia MolinaSalary
Location
France, Paris
Location
Paris
Lisbon
Bucharest
Barcelona
Madrid
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate IIAt 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
Reference
JR119487
Expiry date
01/01/0001
Author
Jaziara HancoxAuthor
Jaziara Hancox