Associate Director, Clinical Site Management, Monitoring Oversight

Madrigal Pharmaceuticals

Associate Director overseeing clinical site monitoring for Madrigal’s MASH therapeutics. Managing CRA field operations, CRO oversight, site performance, and risk-based monitoring across US trials.

Posted 8/5/2026full-timeRemote • Tennessee • 🇺🇸 United StatesSenior💰 $172,000 - $211,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical operations and monitoring, with a strong focus on managing CRAs and developing training programs. Proficient in utilizing Veeva Vault systems and fostering relationships with sites to ensure compliance and optimal performance.

Highest-signal resume keywords

Clinical Operations ManagementCRA Training Program DevelopmentVeeva Vault Systems ExperienceMonitoring OversightStrategic Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringRisk-Based MonitoringSite QualificationSite InitiationCAPA ManagementMonitoring SOP DevelopmentAnalytics and Dashboard DevelopmentCRA Performance AssessmentResource AllocationRegulatory Terminology

Soft Skills

Interpersonal SkillsInfluencing SkillsVerbal CommunicationTechnical WritingOrganizational Skills

Tools & Technologies

Veeva VaultTMFCTMS

Industry Keywords

Clinical TrialsOutsourced MonitoringSite PerformanceComplianceTherapeutic Areas

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Develop and implement Madrigal’s Monitoring Oversight program for sponsor oversight of outsourced trials
Perform targeted, risk-based 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
Provide sponsor support to CRAs and sites at Site Qualification, Site Initiation, and Monitoring Visits
Develop relationships with Madrigal sites and support compliance and optimal site performance
Resolve compliance, data, and monitoring issues with CROs, trial teams, and sites
Develop and manage an internal Madrigal CRA field force
Create monitoring SOPs, work instructions, job aids, templates, and forms
Develop interview, onboarding, and continuing education materials for CRAs
Allocate CRA resources to studies and sites
Review and approve CRA monitoring schedules, reports, and expenses
Assess internal CRA performance and train and support CRAs
Develop site and monitoring analytics and dashboards
Customize Clinical Site Monitoring Plans for insourced studies
Collaborate with cross-functional stakeholders to meet trial milestones and goals
Represent the CRA Field Force team at trial team meetings
Conduct site network, site, and KOL engagement activities within a regional US territory

Requirements

What you’ll need

Proven track record managing CRAs across various phases and therapeutic areas
Experience developing training programs, systems, and tools for CRAs
Ability to influence peers within a matrixed, fast-paced organization
Strong strategic thinking, problem-solving, and influencing skills
Recent experience with Veeva Vault systems, including TMF and CTMS
Strong interpersonal capabilities and ability to build positive site and CRA relationships
Strong verbal communication and technical writing skills
Fluent in English
Ability to present concepts clearly using scientific and regulatory terminology
Sound organizational skills and ability to work independently and efficiently
Proactive approach to identifying challenges and solutions
Detail-oriented with critical reasoning skills
Bachelor’s degree in life sciences, nursing, pharmacy, or related field
10+ years of clinical operations or monitoring experience
Minimum 2+ years in a field CRA role
Additional 2+ years in a prior CRA Manager or outsourced Monitoring Oversight role
Ability to travel within a regional US territory up to 50%
Located within a one-hour drive of an airport

Benefits

Comp & perks

Equity for all employees
Base pay and bonus eligibility
Flexible paid time off
Medical insurance
Dental insurance
Vision insurance
Life/disability insurance
401(k) traditional, Roth, and employer match offerings
Supplemental life insurance
Legal services
Mental health benefits through the Employee Assistance Program for employees and their family
Reasonable accommodations throughout the hiring process