The Lead Data Manager is responsible for the independent oversight and delivery of all data management activities for assigned clinical studies, ensuring high-quality, reliable clinical trial data in accordance with regulatory standards and Madrigal Pharmaceuticals' operational excellence principles. This position serves as the primary point of contact for Data Management on assigned trials, collaborating with cross-functional teams including Clinical Operations, Biostatistics, Programming, and external vendors. The Lead Data Manager ensures timely and accurate database delivery and plays an active role in continuous improvement of data management processes and standards across the R&D organization.
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 Phase II 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.

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $144,000 - $176,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.