Sr. Manager - Project Manager, Digital Health Technology (DHT) & eCOA

Responsibilities

• Serve as the primary operational Subject Matter Expert (SME) for digital health technologies including eCOA, eConsent, wearables, and sensors
• Provide technical and operational input into protocol development regarding digital tools
• Own end-to-end technical project timelines, study specifications, and User Acceptance Testing (UAT)
• Manage specialized vendor performance, conducting root cause analyses and implementing corrective actions (CAPAs)
• Monitor and manage study-level DHT financial components, including contracts and change controls
• Partner with Clinical Quality to ensure DHT processes align with internal quality systems and regulatory guidance
• Develop and maintain SOPs and process guidance for DHT and eCOA implementation

Requirements

• BA/BS degree in Life Sciences, Computer Science, Public Health, or Information Systems
• 8+ years of experience in biotechnology, pharmaceuticals, or clinical trial technology platforms
• Proven track record in Clinical Operations and eCOA systems development
• Experience leading or participating in ICH/GCP inspections and quality audits
• Understanding of clinical trial conduct, GCP, and study operations
• Ability to travel up to 25%

About the Company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Led by industry veterans, Kardigan utilizes a cutting-edge discovery and translational research platform to develop targeted treatments for cardiovascular diseases.