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Clinical Trial Transparency Manager

  1. United States
2023-102498
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

About the role

This vacancy has now expired. Please see similar roles below...

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) Senior 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.


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

 


You are:

Working knowledge of legal/regulatory requirements and guidelines relating to clinical trial
disclosures
• Good understanding of the clinical development process, including clinical trial design, operations
and results analysis
• Strong organizational, interpersonal and communication skills for effective communication of
information 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 Adobe
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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