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Clinical Trial Manager (Digital HealthCare) - Late phase studies

  1. United States
2022-93186
  1. Project Management
  2. ICON Strategic Solutions

About the role

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


The Clinical Trial Manager (CTM) will support the Digital Healthcare Innovation team. The self-driven incumbent is expected to support the development, implementation and management of clinical studies related to the development of digital health technology, including remote disease monitoring solutions and companion health apps for new drugs. CTM will also support digital vendor selection and interaction.  

 

RESPONSIBILITIES

  • Plan, execute, and manage multiple clinical studies and digital health projects at various stages of ideation across different patient population and therapeutic areas.
  • Provide ongoing support and day-to-day management for multiple digital health projects, including protocol development, vendor communication, clinical site monitoring, data collection, patient compliance, budget management, routine study meetings, and overall implementation ensuring adherence to milestones and timelines.
  • Work closely with internal teams and third-party vendors to coordinate all due diligence activities required for implementing digital health solutions in clinical studies and commercial markets, including vendor assessment, product evaluation, security testing, UATs, reviewing service agreements and SoWs, and preparing training materials.
  • Prepare and present new content for PowerPoint presentations, such as routine progress and productivity updates, timeline projections, data reports, and comparative technology analysis, to be shared with both internal and external stakeholders.
  • Assist in evaluating emerging technologies, such as wearable biosensors, connected devices, and mobile apps designed to collect real-world data and remotely monitor disease progression.
  • Collaborate in a multidisciplinary environment with world-class clinicians, researchers, data scientists, healthcare IT experts, and patient advocacy groups.
  • Assists in planning advisory meetings, webinars, coordinate logistics, scheduling and communication.

 

 


Qualifications

  • BA/BS degree required (advanced degree such as PhD preferred).
  • 5+ years pharmaceutical/healthcare industry experience
  • 5+ years of successful track records and experience in managing clinical trials.
  • Deep understanding of clinical trials, patient enrollment, clinical databases, Good Clinical Practice (GCP) and regulations applicable to the conduct of clinical studies.
  • Experience in enabling digital health technologies, including web/mobile applications, APIs, and ePRO is highly preferred.
  • Strong organizational skills and proven ability to juggle multiple highly demanding projects.
  • Strong analytical mindset and excellent communication skills.
  • Well organized, team player, detail oriented, self-starter, and solution-driven.
  • Proficiency in Microsoft Office products (Excel, Word, and PowerPoint), and web conferencing platforms.
  • 5-10% travel may be required.

Benefits of Working in ICON:

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.

At 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.

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, color, 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.

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