Associate Director, Clinical Site Management, Monitoring Oversight

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

📋 Description

• Develop and execute the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials.

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

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

• Analyze trends across various studies and sites, managing mitigations, resolutions, and CAPAs accordingly.

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

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

• Act as an escalation point for resolving compliance, data, and monitoring issues.

• Develop and roll out the internal Madrigal Monitoring program.

• Build and oversee a team of Madrigal CRAs.

• Create controlled monitoring documents and tailor them for insourced trials.

• Design interview, onboarding, and ongoing education materials for CRAs.

• Allocate internal CRA resources to specific studies and sites.

• Review and authorize CRA Monitoring Visit schedules, reports, and expenses.

• Evaluate and manage the performance of internal CRAs, providing training and support as needed.

• Develop analytics and dashboards for site and monitoring performance.

• Customize Clinical Site Monitoring Plans for trials.

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

• Represent the CRA Field Force team during trial team meetings, sharing site and monitoring metrics, trends, and issues.

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

⛳️ Requirements

• Demonstrated success in managing CRAs across a range of phases and therapeutic areas.

• Experience in creating training programs, systems, and tools for CRAs.

• Capability to influence peers within a matrixed, fast-paced environment.

• Strong skills in strategic thinking, problem-solving, and influencing others.

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

• Excellent interpersonal skills, fostering positive relationships with sites and CRAs.

• Strong verbal communication and technical writing proficiency.

• Proficient in English.

• Ability to present concepts using scientific and regulatory language.

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

• Proactive in identifying challenges and developing solutions.

• Detail-oriented with strong critical reasoning abilities.

• Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree is a plus.

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

• A minimum of 2 years in a field CRA role.

• At least 2 additional years in a prior CRA Manager or Monitoring Oversight position.

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

• Reside within a one-hour drive of an airport.

🏝️ Benefits

• Equity opportunities for all employees.

• Comprehensive Total Rewards strategy, including base pay, bonuses, and equity.

• Flexible paid time off policy.

• Medical insurance coverage.

• Dental insurance options.

• Vision insurance plans.

• Life and disability insurance.

• 401(k) offerings, including traditional, Roth options, and employer match.

• Supplemental life insurance available.

• Legal service benefits.

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

• Reasonable accommodations provided throughout the hiring process.