Study Start Up Associate I

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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.

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.

The Role

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team.  As a member of the Study Start Up Team, you will play an integral role in ensuring that physicians at our research sites are well-prepared to commence clinical trials for investigational products at their local practices.

What you will be doing

• Start-up Document Management: Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation including but not limited to:
  • Ethics/regulatory documentation for clinical trial agreements and amendments to the EC, CA and other relevant authorities.
  • Prepare submission dossier and perform submissions to EC and RA
  • Review, contribute and translate Drug Labels.
  • Collect relevant critical documents for IP release.
• Contract and Budget Review Expertise: Review and negotiate clinical site investigator contracts and budgets to ensure fair and compliant agreements.
• Seamless Communication and Collaboration:
  • Maintain effective communication with investigative sites, sponsors, EC and other authorities responding to all relevant queries as they arise.
  • Ensuring all internal personnel are provided with relevant updates or issue resolutions.
  • Attending study meetings and potential kick-off meetings as required.
• Training Material Development and Delivery: Develop and update training documentation and conduct group training, as necessary inline with any industry and local authority changes.
• Mentorship and Personnel Development: Mentor and train new and junior personnel in the Study Start Up department.
• Strategic Expertise in Contract and Budget Development: Provide expert advice and consultation on the Start-up, or Investigator Contract and Budget development process from origination through execution.

Your Profile

• A high school diploma or local equivalent or a Bachelor’s Degree preferably in Life Sciences
• Previous experience in Study Start Up (SSU) is required
• Experience of Clinical Trial operations and meeting regulatory guidelines
• Preferred proficiency in a clinical research environment, specific experience in study contracts review and budget negotiation, or related field where contract or legal document review is a primary part of your role.
• Good knowledge of ICH-GCP

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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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.

ICON, including subsidiaries, 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, colour, 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