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Clinical Program Manager

IDoven

IDoven

Operations
Madrid, Spain
Posted on Oct 23, 2024

About us

Idoven is on a mission to prevent heart disease with AI-powered cardiology. With our breakthrough technology to analyze the heart, we help find patients in need of treatment, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly and safely.

This is a unique opportunity. With the backing of top-tier global investors, including Insight Partners, Northzone and the European Commision (EIC and Horizon H2020), you'll have the responsibility and resources to shape the creation of a game-changing product that can save millions of lives.

Idoven has been honored with numerous awards, including recognition from UCSF as one of the the best new health applications of AI, CB Insight's top 150 in digital health, the European Seal of Excellence, Best Startup at MEDICA (world's largest medical event), Most Disruptive Startup and Best Health Startup at South Summit, and the Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine.

About you

The Clinical Program Manager is responsible for the design, management, execution of the assigned clinical studies / projects for regulatory submission or evidence generation, in support of the development of artificial intelligence algorithms in the cardiology space to impact the next generation of patient care, to achieve team-level goals.

What will you do

  • Design clinical study protocols with the support of the Team Manager, and develops the project plan in consultation with Idoven clinical team and under the supervision of the Team Manager
  • Ensure the execution of assigned clinical studies with the goal of adhering to target timelines, budget and quality
  • Ensure the clinical studies are audit-ready at all times (e.g. project team training records, central files, system validation, etc.)
  • Medical oversight during trials and functions as SME for scientific and medical questions during the trials
  • Support all investigators and centres involved in multi-centre studies
  • Prepare the documentation required for Ethics Committee approvals under the supervision of the Team Manager
  • Conduct on-site visits to support qualifications, training on implementation and conduct of study protocols
  • Provide oversight of clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed
  • Be involved in control of device distribution and allocation
  • Evaluate clinical data in preparation of study summary reports for presentations, publications and submissions
  • Engage with Key Opinion Leaders to collect their input as needed for the clinical project