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

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus
10+ years of clinical operations or monitoring experience, with a minimum of 2+ years in a field CRA role, and additional 2+ years in a prior CRA Manager or Monitoring Oversight (of outsourced monitoring) role
Ability to travel 50%, on average
Proven track record of successfully managing CRAs across various phases and therapeutic areas
Experience with developing training programs, systems and tools for CRAs
Demonstrated ability to influence peers within a matrixed and fast-paced organization
Strong strategic thinking, problem-solving, and influencing skills
Recent experience with Veeva Vault systems (TMF, CTMS)

Benefits

Flexible paid time off
Medical, dental, vision and life/disability insurance
401(k) offerings (i.e., traditional, Roth, and employer match)
Voluntary benefits like supplemental life insurance, legal services, and other offerings
Mental health benefits through our Employee Assistance Program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical operationsmonitoring experiencerisk-based approachtraining program developmentcompliance managementdata managementCAPA managementSOP creationsite qualificationsite initiation

Soft Skills

strategic thinkingproblem-solvinginfluencing skillsrelationship buildingcommunicationteam managementcollaborationadaptabilityleadershiporganizational skills