Clinical Trial Transparency Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

As a Clinical Trial Transparency Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Trial Data Transparency (CTDT) Manager is responsible for the operational
execution of Vertex’s clinical trial disclosure activities, including protocol registration and results
postings, on local, national or regional clinical trial registries. The CTDT Senior Manager will partner
closely with functional groups and other internal stakeholders to ensure that trial disclosures adhere
to internal processes/strategy and comply with all applicable laws, regulations, policies and registry
requirements. The role will also contribute to the development and maintenance of processes and
standards that support Vertex compliance with current or future global clinical trial disclosure
requirements.

You are:

What you will be doing:

Plans and executes clinical trial registrations, results postings, and maintenance of trial registry
records, according to all applicable laws, regulatory requirements and policies
• Consults with internal stakeholders and functions to ensure that clinical trial registration and

Conducts quality reviews of clinical trial disclosure deliverables, tracks compliance and compiles
metrics for all disclosure-related activities
• Acts as a clinical trial disclosure liaison to study teams in communicating Vertex disclosure policies,
processes, and system requirements to ensure compliance
• Supports and/or develops relevant training and process-related documents, including internal
guidance, standard operating procedures (SOPs) and work instructions (WIs)
• Acts as the coordinator for external data sharing requests and clinical trial disclosure strategy
meetings, including drafting of responses, agendas and meeting minutes
• Works with GIS/GCO and other functions to implement technology solutions related to clinical trial
disclosures

• Working knowledge of legal/regulatory requirements and guidelines relating to clinical trialdisclosures• Good understanding of the clinical development process, including clinical trial design, operationsand results analysis• Strong organizational, interpersonal and communication skills for effective communication ofinformation in complex situations• Demonstrated analytical skills and ability to interpret scientific content• Ability to work in a team environment and across all levels of the organization• Ability to multitask and prioritize multiple projects under evolving timelines• Competent in Microsoft Office (Word, Excel, PowerPoint) and Outlook; experience with AdobeAcrobat
BS or BA Degree required

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

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.

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.