Lead Data Manager

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 Phase3 outcome 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. Key Responsibilities Serve as the Data Management lead for one or more clinical studies, accountable for end‑to‑end data management activities from study start‑up through database lock. Develop and maintain study‑level Data Management Plans (DMPs), CRF completion guidelines, edit check specifications, and other data management documentation. Lead EDC system setup, user acceptance testing (UAT), and database change control in collaboration with vendors and internal teams. Coordinate and perform ongoing data review, query management, and data cleaning activities to ensure data integrity and completeness. Oversee external data handling, including laboratory, ECG, imaging, PK/PD, and ePRO integrations, ensuring timely reconciliation and issue resolution. Monitor study progress, track data metrics, and proactively identify and address data‑related risks and delays. Lead database lock planning and execution, including review of data listings and coordination of cross‑functional deliverables. Serve as the primary point of contact for CROs, EDC vendors, and functional partners for assigned studies. Ensure compliance with Madrigal SOPs, GCP, ICH, and regulatory requirements in all data management activities. Contribute to process improvement initiatives and provide input on departmental tools, templates, and standards. May provide training, mentoring, and oversight to junior data management staff. Qualifications and Experience Bachelor’s degree in Life Sciences, Computer Science, or related field. Minimum of 5–7 years of experience in clinical data management within the pharmaceutical or biotechnology industry, including study‑level lead experience. Demonstrated proficiency with EDC systems such as Medidata Rave, Oracle InForm, or Veeva CDMS. Strong understanding of clinical data standards (CDASH, SDTM) and data integration practices. Working knowledge of ICH GCP, FDA, and other regulatory guidelines relevant to clinical research. Proven ability to manage vendor deliverables, timelines, and budgets. Excellent organizational, analytical, and problem‑solving skills. Strong written and verbal communication skills with experience presenting data management deliverables cross‑functionally. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). Preferred Experience Experience leading data management for PhaseII or III global studies. Familiarity with adaptive trial designs and complex data models. Experience managing data from multiple external vendors (e.g., imaging, central labs, ECG, ePRO, PK/PD). Exposure to therapeutic areas such as oncology, metabolic, or cardiovascular disease. Experience participating in regulatory inspections or sponsor audits. Familiarity with data review and visualization tools (e.g., JReview, Spotfire, SAS listings). Core Competencies Leadership: Provides direction and coordination to study teams and external partners. Accountability: Drives data management deliverables to completion with minimal supervision. Quality Focus: Maintains meticulous attention to data accuracy, completeness, and documentation integrity. Collaboration: Works effectively with cross‑functional teams to achieve clinical program milestones. Continuous Improvement: Identifies and implements process enhancements that optimize data flow and efficiency. Total Rewards and Benefits Base salary range: $144,000 – $176,000 per year (as of the posting date). Equity: All employees receive equity, reinforcing our ownership culture; offers meaningful opportunity for employees to share in company success. Comprehensive benefits for full‑time employees, including flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) plans (traditional, Roth, and employer match). Additional voluntary benefits, such as supplemental life insurance, legal services, and other offerings. Mental health benefits through our Employee Assistance Program for employees and their families. We comply with all applicable minimum wage laws. Equal Employment Opportunity Statement Madrigal is an Equal Opportunity Employer. All employment decisions are made on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or any characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr