As a Principal Study Start Up Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Principle Study Start Up Associate is responsible for coordinating the operational and strategic aspects of clinical trial submissions applicable for countries in scope of the EU CTR for internally managed, and/or outsourced, trials, including compound level coordination. They co-ordinate the EU CTR operational clinical trial submission strategy - and develops, drives and monitors timelines/milestones. They work with central teams and country teams to ensure all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.
Responsibilities include planning a compound and trial level EU CTR combined operational submissions strategy with relevant cross-functional involvement throughout the entire trial lifecycle. This role will be responsible for driving the discussions, consolidate input from all stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy. In addition, this role will be responsible for coordinating submissions in the CTIS portal.
This position interfaces with stakeholders internal and external to Global Operations functions, such as the Start Up Associates, GCO Country Local Submission Coordinator (local point-of-contact), Clinical Trial Manager (CTM), Global development Trial Leader (GTL), Global Regulatory Clinical Trial Application Submissions Manager (Global CTA SM), CRO point of contact, and other relevant functional area stakeholders as needed. They collaborate closely with the GTL, CTM (if applicable), LPOC and CTA SM, and are a member of the Trial Team.
Major Duties/Responsibilities operations:
•Lead the EU Submission strategy development, planning and delivery as a member of the Cross Functional Trial Team (CFTT)
•Clinical trial planning, submissions and notifications
•Financial planning and tracking
•Cross functional submission management
•Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
•BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
•Required: Global clinical research regulation knowledge and understanding, strong project planning/management expertise and effective communication skills.
•Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
•Proven track record in successfully managing multinational clinical trial submissions to Health Authorities and or/ Ethics Committees.
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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