Clinical Trial Manager

Clinical Trial Manager

Princeton, New Jersey

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition 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 that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals.

Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day.

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

• 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

Exact Compensation may vary based on skills, experience and location.

Pay range

$140,000 - $182,000 USD