Study Start Up Associate

1 month ago

Shefford, United Kingdom ICON Plc Full time
Study Start Up Associate / Regulatory Submissions

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 / Regulatory Submissions

Serving as a primary contact for investigators and research coordinators, you will perform EC submissions and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release.

Role Responsibility
Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams.

• Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies

• Develop, finalize and review Master and Country Specific Subject Information Sheets

• Perform independent quality review of submission packages.

• Responsible for the translation and co-ordination of translations for documents required for submissions.

• Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system

What you need
• Bachelor’s Degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline
• A minimum of 2 years of hands on experience in Clinical Study Start-up area
• Good organizational skills and the ability to manage multiple tasks

• Good written and verbal communication skills.

. Proficient in English language required for country assignments

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

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