ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As a Senior Study Start Up Associate you will play a key player in differentiating ICON by accelerating site start-up through effective execution of regulatory approvals and of site contracts ensuring sites are ready to enrol patients as quickly as possible. This role may serve as Site Activation Lead when appropriate. Ensuring timely collection of critical documents in order to begin patient enrolment. Critical path to study initiation.
You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally
What you will be doing:
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality site level documents leading to sites initiation approval
- Register investigator sites and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
- Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to site essential documents components, study contracts contacts, payment information, ethics/IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of issues where applicable
- Prepare, validate and submit applicable study documents such as ICDs, for internal regulatory/Legal approval within required timelines
- Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation
- Take the Lead and Coordinates the compilation of the local or Central Investigator Review Board (IRB) package and submissions to approval of the study
- Coordinate the timely communication, documentation and responses between the sponsor and Central Ethics committee to bring study to approval (country dependent)
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Qualifications:
- At least 3-4 years of experience supporting startup and regulatory submissions in Argentina.
- Knowledge of local regulatory authority drug research and development regulations required.
- Clinical trials support or pharmaceutical industry experience required.
- Bachelor in helth degree is a plus.
- Advanced level of English.
- 100% Home Office
Why ICON?
At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
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.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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, 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.
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