Regulatory Affairs Manager

As a (job title) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Start- up Associate I supports the operational aspects of all clinical trial submissions made under the EU CTR, in the EU Clinical Trial Information System (CTIS), for internally managed trials. He will work in support of the EU Clinical Trial Submission Coordinator (EU CTSC), Regulatory CTA SM and GCO country teams to make all clinical trial initial submissions, clinical trial amendment submissions and clinical trial notifications in CTIS and track the progress of submissions/notifications.

What you will be doing:

Responsibilities include but are not limited to generation of progress tracking reports, analysis and follow-up, system data entry, setting up meetings and maintaining minutes, document management and transfer into CTIS, as relevant for initial submissions, substantial amendments and notifications for assigned clinical trials.

Job responsibilities:

• Assist in study specific submissions document management and document collation for submission.
• Perform document quality and completeness checks.
• Transfer submission package to CTIS, make submission in CTIS and perform submission archiving.
• Ensure the current submission status and tracking of related information is available at all times in the appropriate clinical trial management system(s) (CTMS). Work with EU CTSC, Local Trial Managers and Site Managers, GCO country Local Submission Coordinator, CRO to ensure submissions data are up-to-date, complete, and accurate during all phases of the trial.
• Support submission coordination activities and tracking of submission timelines and deliverables to ensure trial delivery according to agreed upon timelines/milestones.
• Responsible for review/management of CTIS for completeness and timely entry of information into CTIS.
• Assist EU CTSC, Regulatory CTA SM, CTM and GTL with applicable CTIS support.
• Provide overview of submission/substantial amendment/notification management metrics as needed.

You are:

Qualifications

• Associate’s degree (or equivalent) required and at least 1 year of experience in submissions as CTA, Start up Assistant or Study Coordinator.
• Excellent organization skills, excellent written and verbal communication skills.
• Excellent independent time management skills.
• Proven ability to plan and track deliverables and timelines.
• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
• Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD.

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.