Associate Director, Clinical Site Management and Monitoring Oversight
Madrigal Pharmaceuticals
August 10, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Key Responsibilities
- Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program for sponsor oversight of outsourced trials.
- Use a risk-based approach to conduct 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; manage mitigations, resolutions, and CAPAs.
- Support CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits.
- Develop site relationships to drive compliance and optimal site performance.
- Serve as a Madrigal escalation resource to resolve compliance, data, and/or monitoring issues.
- Develop and manage an internal CRA field team (CRA Field Force), including training and performance oversight.
- Create controlled Monitoring documents (SOPs, work instructions, job aids, templates/forms) and customize for insourced trials.
- Develop interview/onboarding/continuous education training materials; allocate CRA resources to studies/sites; review/approve monitoring schedules, reports, and expenses.
- Develop internal site/monitoring analytics and dashboards; customize Clinical Site Monitoring Plans.
- Represent CRA Field Force at trial meetings; conduct site network/site/KOL engagement within the region.
Qualifications
- 10+ years clinical operations or monitoring experience; 2+ years as a field CRA; additional 2+ years as CRA Manager or in monitoring oversight (outsourced monitoring).
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus).
- Strong interpersonal and relationship-building skills; strong verbal communication and technical writing; fluent in English.
- Ability to present scientific/regulatory concepts; strong organization; proactive problem-solving; detail-oriented.
- Recent Veeva Vault experience (TMF, CTMS).
- Travel up to 50% within a regional US territory; located within a one-hour drive of an airport.
Benefits
- Full-time employees: flexible paid time off; medical, dental, vision, and life/disability insurance; 401(k) (traditional, Roth, and employer match).
Application Instructions
- Applications accepted on an ongoing basis via the Madrigal Careers site.
- Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program for sponsor oversight of outsourced trials.
- Use a risk-based approach to conduct 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; manage mitigations, resolutions, and CAPAs.
- Support CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits.
- Develop site relationships to drive compliance and optimal site performance.
- Serve as a Madrigal escalation resource to resolve compliance, data, and/or monitoring issues.
- Develop and manage an internal CRA field team (CRA Field Force), including training and performance oversight.
- Create controlled Monitoring documents (SOPs, work instructions, job aids, templates/forms) and customize for insourced trials.
- Develop interview/onboarding/continuous education training materials; allocate CRA resources to studies/sites; review/approve monitoring schedules, reports, and expenses.
- Develop internal site/monitoring analytics and dashboards; customize Clinical Site Monitoring Plans.
- Represent CRA Field Force at trial meetings; conduct site network/site/KOL engagement within the region.
Qualifications
- 10+ years clinical operations or monitoring experience; 2+ years as a field CRA; additional 2+ years as CRA Manager or in monitoring oversight (outsourced monitoring).
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus).
- Strong interpersonal and relationship-building skills; strong verbal communication and technical writing; fluent in English.
- Ability to present scientific/regulatory concepts; strong organization; proactive problem-solving; detail-oriented.
- Recent Veeva Vault experience (TMF, CTMS).
- Travel up to 50% within a regional US territory; located within a one-hour drive of an airport.
Benefits
- Full-time employees: flexible paid time off; medical, dental, vision, and life/disability insurance; 401(k) (traditional, Roth, and employer match).
Application Instructions
- Applications accepted on an ongoing basis via the Madrigal Careers site.