Associate Director, Clinical Site Management, Monitoring Oversight

🔥 2 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – 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 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

• 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

• 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