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 desirable but not 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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