Clinical Trial Manager, Clinical Operations

About this role

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

The Clinical Trial Manager is an experienced clinical operations professional responsible for independently leading the operational execution of global clinical trials within a rapidly growing biotechnology company. The Clinical Trial Manager partners closely with other members within Clinical Operations, cross-functional functional areas, CROs, vendors, and investigational sites to drive successful study execution across multiple phases of clinical development. This role independently manages one or more clinical studies or major study components, ensuring operational excellence throughout the study lifecycle. The Clinical Trial Manager provides oversight of study timelines, vendor performance, budgets, Trial Master File quality, and inspection readiness while proactively identifying and mitigating operational risks. The role serves as the primary operational lead for assigned studies, mentors Associate Clinical Trial Managers and Clinical Trial Specialists, and contributes to process improvements that enhance operational efficiency while ensuring compliance with ICH-GCP, applicable regulatory requirements, and company SOPs. Key Responsibilities • Independently lead day-to-day operational management of one or more assigned global clinical trials (Phase I–IV). • Serve as the primary operational lead for assigned studies, ensuring study milestones, timelines, budgets, quality expectations, and operational deliverables are achieved. • Lead and coordinate clinical trial start-up, maintenance, close-out, and inspection readiness activities with minimal supervision. • Develop, review, and finalize key study documentation including study plans, operational manuals, monitoring plans, newsletters, trackers, informed consent forms (ICFs), protocols, protocol amendments, and other operational documents. • Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the study lifecycle. • Proactively identify study risks and operational challenges while implementing appropriate mitigation strategies and escalating significant issues to Clinical Operations leadership when appropriate. • Lead operational oversight of CROs and vendors, including performance management, issue resolution, deliverable tracking, and ongoing relationship management. • Coordinate investigator and site selection activities in collaboration with Clinical Operations leadership and CRO partners. • Support and oversee investigational site activation activities, including review of regulatory documentation and essential study documents. • Lead operational study meetings, prepare meeting agendas and minutes, and ensure action items are completed within established timelines. • Collaborate with Data Management, Clinical Supply, Biometrics, Regulatory Affairs, Pharmacovigilance, Medical Writing, and other cross-functional teams to support successful study execution. • Monitor study enrollment, subject tracking, data quality metrics, and overall study progress while ensuring protocol compliance. • Support protocol amendments, regulatory submissions, health authority inspections, and internal and external audits. • Participate in User Acceptance Testing (UAT) activities for CTMS, eTMF, EDC, IRT, and other clinical systems. • Monitor investigator payments, study budgets, contracts, purchase orders, and vendor invoices while ensuring financial accountability. • Contribute to CRO selection, vendor onboarding, oversight, and performance management activities. • Identify opportunities for operational efficiencies and contribute to the development and refinement of Clinical Operations SOPs, work instructions, templates, and best practices. • Mentor Associate Clinical Trial Managers, Clinical Trial Specialists, and other Clinical Operations personnel, as appropriate. • Perform additional responsibilities as assigned.

Required & Desired Qualifications Competencies • Strong knowledge of clinical trial operations across all phases of development and comprehensive understanding of ICH-GCP guidelines. • Demonstrated experience independently managing operational aspects of multiple concurrent global clinical trials. • Experience providing operational leadership for assigned studies while collaborating effectively with CROs, vendors, investigational sites, and cross-functional teams. • Working knowledge of FDA regulations, global clinical trial requirements, and inspection readiness activities. • Demonstrated ability to proactively identify operational risks, implement mitigation strategies, and drive issue resolution. • Strong project management skills with the ability to prioritize competing demands while managing multiple studies simultaneously. • Excellent organizational skills with exceptional attention to detail. • Strong interpersonal, written, verbal, and presentation skills with the ability to effe

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