Clinical Trial Transparency Manager

As a Clinical Trial Transparency Manager 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 the sponsors clinical trial disclosure activities, including protocol registration and results postings, on local, national or regional clinical trial registries. The CTDT 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 the sponsors compliance with current or future global clinical trial disclosure requirements.

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 results postings are accurate and adhere to internal policy /strategy and registry requirements
• 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 the sponsors 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
• Works with vendors providing trial disclosure services to the sponsor

You are:

Passionate, innovative and committed.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Bachelor's degree in a scientific discipline, or other relevant discipline
• Typically requires 4 years of experience in pharmaceutical industry and/or clinical research experience, or the equivalent combination of education and experience
• Experience within clinical trial disclosure activities

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

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.

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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