Associate Director, Clinical Site Management and Monitoring Oversight

Associate Director, Clinical Site Management and Monitoring Oversight page is loaded## Associate Director, Clinical Site Management and Monitoring Oversight locations:
PA - Pennsylvania – Remote time type:
Full time posted on:
Posted Todayjob requisition :
is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH.

Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Job Description This role will partner with the Sr Director to develop the Clinical Monitoring Oversight program, and to build and manage an internal US CRA (Monitoring) field force. The Associate Director partners with CROs and cross-functional teams to drive monitoring performance and operational excellence at the CRA and site levels by performing targeted and risk-based oversight activities and collaborating with the cross-functional trial team to manage and resolve issues.

The Associate Director engages Madrigal sites and networks to develop relationships and support optimal site performance within Madrigal trials. The Associate Director will also manage an internal CRA field team within their region of the US.
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* Key Responsibilities:

**** Monitoring Oversight
** o Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trialso Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territoryo 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 neededo Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visitso Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performanceo Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues
** CRA Field Force Team Development and Management
** o Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring programo Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trialso Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trialso Partner with the Sr Director of CRA Field Force to develop interview, onboarding, and continuous education training materials for Madrigal CRAso Strategically allocate internal CRA resources to studies and siteso Review and approve Madrigal CRA Monitoring Visit schedules, reports and expenseso Perform Monitoring Oversight Visits to assess and manage internal CRA performanceo Support internal CRAs and engage with sites at Site Qualification Visits and Site Initiation Visitso Partner with the Sr Director of CRA Field Force and cross-functional stakeholders to develop internal site and monitoring analytics and dashboards to assess site health…