Associate Director, Clinical Site Management, Monitoring Oversight

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $172k - $211k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Madrigal Pharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $259M Post-IPO Equity on 2022-12

Healthcare • Pharmaceuticals • Biotechnology

Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.

📋 Description

• Develop and implement the Madrigal Monitoring Oversight program for sponsor oversight of outsourced trials • Perform 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 • Support CRAs and sites at Site Qualification, Site Initiation, and Monitoring Visits • Develop relationships with Madrigal sites to drive compliance and optimal performance • Serve as an escalation resource to resolve compliance, data, and monitoring issues • Develop and implement the internal Madrigal Monitoring program • Build and manage a group of Madrigal CRAs • Create controlled monitoring documents and customize them for insourced trials • Develop interview, onboarding, and continuous education materials for CRAs • Allocate internal CRA resources to studies and sites • Review and approve CRA Monitoring Visit schedules, reports, and expenses • Assess and manage internal CRA performance and train and support CRAs • Develop site and monitoring analytics and dashboards • Customize trial Clinical Site Monitoring Plans • Collaborate with cross-functional stakeholders to meet trial milestones and goals • Represent the CRA Field Force team at trial team meetings and share site and monitoring metrics, trends, and issues • Conduct site network, site, and KOL engagement activities within a regional US territory

🎯 Requirements

• 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 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; advanced degree a plus • 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 Monitoring Oversight role • Ability to travel within a regional US territory up to 50% • Located within a one-hour drive of an airport

🏖️ Benefits

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