Clinical Trial Manager

Kardigan is seeking a Clinical Trial Manager to contribute to the planning, oversight and delivery of its cardiovascular clinical studies. As a Clinical Trial Manager (CTM), you will be part of the Clinical Operations team reporting to the asset’s Clinical Trial or Clinical Program Lead. This position will be responsible for the oversight and management of Clinical Research Organizations (CROs) and vendors and will work cross-functionally on the trial operations’ strategy and related initiatives. This role is pivotal in ensuring key project deliverables, primarily from CROs and vendors, are met according to the budget, timelines and quality standards (as defined by regulations, SOPs, and ICH-GCP) with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

 4 Day Onsite Schedule - M - Th

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 participate in CRO and vendor meetings and study execution meetings

• Support 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

• Responsible for maintaining Action/Decision and Issue/Issue Resolution logs for assigned CRO/vendor management
• Ensure CAPAs are in place, if applicable

• Contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

Here’s what you’ll bring to the table

• Minimum of BA/BS with approximately 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