This individual performing the services is responsible for Supporting the Project Management of RTSM including (but not limited to) development, UAT testing, administration of documentation and use of RTSM (aka IWRS) systems for the management of clinical supplies and subjects during the execution phase of clinical trials.
What you will be doing:
Provide Advice/recommendation to study teams regarding the supplier and system design alternatives
Provide Requests for Proposal documentation, and recommend appropriate suppliers to support study needs
Provide leadership and subject matter expertise for the completion of supplier set-up activities through lifecycle of the IVR/IWR system
Lead the cross functional study team through changes of scope for IVRS/IWRS, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates and user acceptance testing
Lead the resolution of issues escalated by study teams as well as cross-team specific issues under the supervision of the Director or Associate Director, RTSM as applicable
Demonstrate sufficient knowledge of randomization and medication assignment processes to be able to perform required un-blinded assessments of the IVR/IWR system performance (or functionality) should that be assigned
Serve as the point of contact specific to inspection readiness activities between the study team and the IVRS/IWRS supplier
Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables
Monitor key performance indicators for services provided by external service providers
Conduct Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process
Effectively support the study team in close-out/deactivation of the IVR/IWR system
You are:
At least 6 years operational experience in clinical trials with a pharmaceutical
company and/or a Clinical Research Organization is required
Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
Familiarity with industry best practices for vendor management is required
Good understanding of the therapeutic areas
Experience with IVRS/IWRS suppliers is preferred
Strong project management skills and presentation skills with the ability to lead a team independently.
Bachelor’s degree (University degree) or equivalent education required; advanced
degree preferred
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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.
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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