Madrigal Pharmaceuticals

Director

• Partner with the Sr Director to develop the Clinical Monitoring Oversight program
• Build and manage an internal US CRA (Monitoring) field force
• Drive monitoring performance and operational excellence at the CRA and site levels by performing oversight activities
• Engage Madrigal sites to develop relationships and support optimal site performance within Madrigal trials
• Manage an internal CRA field team within their region of the US

Associate Director, Clinical Site Management, Monitoring Oversight

• Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials
• Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territory
• Document and communicate visit findings to CRO partners and Madrigal stakeholders; assess trends across studies and sites; and manage mitigations, resolutions and CAPAs to remediate identified issues as needed
• Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits
• Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performance
• Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues
• Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trials
• Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trials
• Strategically allocate internal CRA resources to studies and sites

Associate Director, Clinical Site Management, Monitoring Oversight

Associate Director – Clinical Site Management and Monitoring Oversight