Clinical Registry Coordinator

Overview

As a Clinical Registry Coordinator you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

1. Provides clinical registry support, oversight and/or accountability for one or more development programs for clinical trials.
2. Takes a leadership role with the clinical development team and other internal and external partners to establish, align and confirm clinical registry expectations for assigned trial(s).
3. Develops and delivers the Disclosure Plan with the CDTL and Patent attorney.
4. With the CDT and other functional partners: - Gathers content and integration requirements for registration records - Establishes expectations for dataset content and - Set timelines and follow-up regularly to ensure delivery of all clinical trial disclosure milestones.
5. Responsible for submission of approved documents and content to registries worldwide. Submissions are made by the Clinical Registry Administrators, either directly such as for clinicaltrials.gov or the EU clinical trial register, or indirectly by providing to the local operating company staff for subsequent submissions to local registries.
6. Responsible for tracking, reporting and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group.
7. Assisting business partners, external partners and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process.
8. Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning.
9. Ensures deliverables are on track.
10. Participates in assigned working group(s) to ensure that clinical registry and Therapeutic Area trial needs and deliverables are met.
11. Helps identify and communicate lessons learned, best practices and frequently asked questions at the trial.
12. Presents and trains at business partner meetings, if required.
13. Works closely together with other CRCs and with clinical registry managers to ensure alignment and information sharing across all development programs.

Qualifications

You are:

1. A minimum of 4 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO or other clinical development service organization) is required.
2. Bachelor's degree in Health or Science discipline with experience in clinical research (typical roles: clinical trial manager, junior global trial leader, lead data manager, regulatory submissions lead).
3. Clinical Registry experience preferred.
4. Experience working on a clinical trial or regulatory document management preferred.
5. Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
6. Project management experience.
7. Vendor management experience.
8. Advanced Microsoft Office skills including the ability to manipulate and analyze data.

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.