Clinical Trial Manager

About Us

Kardigan is a heart health company dedicated to making cardiovascular disease preventable, curable, and no longer the leading cause of death worldwide. Our mission is to develop multiple targeted treatments in parallel to bring people with cardiovascular diseases to the cures they deserve. Founded by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have a history of success, having led MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, which was acquired by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving the lives of patients. Our values guide our work, interaction, and goal achievement, emphasizing authenticity, curiosity, teamwork, and innovation.

Responsibilities

• Supports the Clinical Trial Lead (CTL) in the oversight and management of study CROs to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Coordinates and contributes to the review of relevant study plans and documents including protocols, informed consent forms, project management and monitoring plans, vendor study documents
• Responsible for management of select study vendors including review of vendor study operational plans, key performance metrics, risks identification and mitigation
• Proactively escalates issues to the Clinical Trial Lead to ensure timely resolution of issues and overall inspection readiness
• Develops and coordinates the review and maintenance of vendor oversight plans in conjunction with the Clinical Trial Lead and other trial team members
• Supports the Clinical Trial Lead in planning and maintaining study timelines, ensuring the cross functional project team remains on track for project and study deliverables
• Actively participates in CRO and vendor meetings and study execution meetings
• Supports the operational strategy related to assigned vendors, data flow, drug supply, remote patient monitoring and any/all decentralized trial processes
• Tracks, monitors and reports on study progress
• Manages CRO and vendor budgets and invoicing procedures according to study contract
• Summarizes CRO and vendor performance data and escalates risk to the Clinical Operations Program Lead and/or Head of Development Operations, as needed
• Ensures CAPAs are in place, if applicable
• Contributes to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

Qualifications

• BA/BS with 7+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs
• Experience within the field of cardiovascular studies and/or rare disease is desirable
• Experience in early and late stage drug development; late-stage development is desirable
• Independent professional who proactively communicates frequently and effectively
• Detail and action-oriented, organized and committed to quality and consistency
• Ability to work successfully in cross-functional teams
• Ability to work in a dynamic environment with a high degree of flexibility
• Expertise in Microsoft Smartsheets desired
• Experience in ICH/GCP inspections, audits and inspection preparedness
• 20% of travel required

Pay

Exact Compensation may vary based on skills, experience and location. Pay range $140,000 - $182,000 USD