Associate Director, Clinical Site Management, Monitoring Oversight

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Design and execute Madrigal’s Monitoring Oversight program to ensure sponsor supervision of outsourced trials.

• Conduct targeted, risk-based remote and on-site Monitoring Oversight Visits across a designated regional US territory.

• Record and relay visit findings to CRO partners and Madrigal stakeholders.

• Evaluate trends across studies and sites, managing mitigations, resolutions, and CAPAs.

• Offer sponsor support to CRAs and sites during Site Qualification, Site Initiation, and Monitoring Visits.

• Foster relationships with Madrigal sites to promote compliance and enhance site performance.

• Address compliance, data, and monitoring challenges alongside CROs, trial teams, and sites.

• Build and oversee an internal Madrigal CRA field force.

• Develop monitoring SOPs, work instructions, job aids, templates, and forms.

• Create materials for interviews, onboarding, and ongoing education for CRAs.

• Assign CRA resources to studies and sites effectively.

• Review and authorize CRA monitoring schedules, reports, and expenses.

• Evaluate internal CRA performance and provide training and support to CRAs.

• Develop analytics and dashboards for site and monitoring activities.

• Tailor Clinical Site Monitoring Plans for insourced studies.

• Collaborate with cross-functional stakeholders to achieve trial milestones and objectives.

• Represent the CRA Field Force team during trial team meetings.

• Engage in site network, site, and KOL activities within a regional US territory.

⛳️ Requirements

• Demonstrated success in managing CRAs across different phases and therapeutic areas.

• Experience in developing training programs, systems, and resources for CRAs.

• Ability to influence peers in a matrixed, fast-paced environment.

• Strong strategic thinking, problem-solving, and persuasive abilities.

• Recent familiarity with Veeva Vault systems, including TMF and CTMS.

• Excellent interpersonal skills and capacity to cultivate positive relationships with sites and CRAs.

• Strong verbal communication and technical writing capabilities.

• Proficient in English.

• Ability to articulate concepts clearly using scientific and regulatory language.

• Excellent organizational skills with the ability to work independently and efficiently.

• Proactive in identifying challenges and devising solutions.

• Detail-oriented with strong critical reasoning abilities.

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.

• Over 10 years of experience in clinical operations or monitoring.

• At least 2 years in a field CRA role.

• An additional 2 years in a prior CRA Manager or outsourced Monitoring Oversight position.

• Willingness to travel within a regional US territory up to 50%.

• Must reside within a one-hour drive of an airport.

🏝️ Benefits

• Equity for all employees.

• Base salary plus bonus eligibility.

• Flexible paid time off.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life/disability insurance.

• 401(k) traditional, Roth, and employer matching options.

• Supplemental life insurance.

• Legal services.

• Mental health support through the Employee Assistance Program for employees and their families.

• Reasonable accommodations provided throughout the hiring process.