Remote Clinical Program Manager

Summary

Join Idoven, a mission-driven startup, as Clinical Program Manager to design, manage, and execute clinical studies/projects for regulatory submission/evidence generation in cardiology AI development.

Requirements

• Minimum of 2 years directly supporting clinical research or similar experience in a medical/scientific area
• Proven expertise in the writing of clinical and non-clinical research protocols including trial design and methodology, and research publications
• Experience running multi-centre studies from start to end
• Proficient knowledge of medical terminology in cardiology
• Expertise with Good Clinical Practices (GCPs) and regulatory compliance for clinical trials (e.g. applicable ISO Standards, CE Mark)
• Bachelor’s degree in Statistics, Science, Engineering or related field
• Spanish and English are a must
• Excellent time management, planning, and organizational skills

Responsibilities

• Design clinical study protocols with the support of the Team Manager
• 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