Join Puzzle Medical as a Clinical Program Director, managing clinical trials for medical devices with a focus on operational excellence and compliance. This role is pivotal for trial success and regulatory adherence.
Your role will encompass full oversight of clinical studies, starting from Early Feasibility Studies to pivotal trials. You'll be responsible for site activation, participant enrollment, and hands-on monitoring, ensuring compliance with ICH-GCP and relevant regulations. You'll engage cross-functionally to optimize resources and mitigate operational risks.
Key Responsibilities: • Manage the full lifecycle of clinical trials • Conduct monitoring and site management activities • Establish clinical operations infrastructure for studies • Ensure timely completion of IRB approvals and contracts • Lead internal audits and regulatory inspections