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Clinical Trial Transparency Manager

  1. United States
2023-102499
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

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About the role

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


 

What you will be doing:

  • Plan and execute clinical trial registrations, results postings, and maintenance of trial registry records, according to all applicable laws, regulatory requirements and policies
  • Consult with internal stakeholders and functions to ensure clinical trial registration
  • Conduct quality reviews of clinical trial disclosure deliverables, tracks compliance and compiles metrics for all disclosure-related activities
  • Act as a clinical trial disclosure liaison to study teams in communicating Sponsor disclosure policies, processes, and system requirements to ensure compliance
  • Support and/or develop relevant training and process-related documents, including internal guidance, standard operating procedures (SOPs) and work instructions (WIs)
  • Act as the coordinator for external data sharing requests and clinical trial disclosure strategy meetings, including drafting of responses, agendas and meeting minutes
  • Work with GIS/GCO and other functions to implement technology solutions related to clinical trial disclosures

What you need to qualify:

  • Bachelors' degree required/ Masters degree or higher is preferred.
  • A minimum of 2 years' relevant experience in a CRO, Pharma or Biotech environment
  • 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


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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