Clinical Registry Coordinator

Clinical Registry Coordinator

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Clinical Registry Coordinator at ICON Plc, you will be instrumental in ensuring the transparency and integrity of clinical trial data and results.

What You Will Do:

Key responsibilities include:

Provides clinical registry support, oversight and/or accountability for one or more development programs for clinical trials.

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).

Develops and delivers the Disclosure Plan with the CDTL and Patent attorney.

With the CDT and other functional partners: – Gathers content and integration requirements for registration records – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all clinical trial disclosure milestones.

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

Responsible for tracking, reporting and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group

Assisting business partners, external partners and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process

Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning

Your Profile:

Required qualifications and experience:

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.

Bachelor’s degree in Health or Science discipline with experience in clinical research (typical roles: clinical trial manager, regulatory submissions lead)

Clinical Registry experience preferred

Experience working on a clinical trial or regulatory document management preferred

Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.

Project management skills.

Vendor management skills.

Advanced Microsoft Office skills including the ability to manipulate and analyze data

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

Competitive base salary and performance related incentives

Health and wellbeing programmes including medical, dental, and vision coverage where applicable

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes and wellbeing resources

Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to about the benefits ICON offers.

Inclusion and Accessibility

If you require reasonable accommodations during the recruitment process, please let us know or submit a request .

Are you a current ICON Employee?