Madrigal Pharmaceuticals · 14 hours ago
Lead Data Manager
Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic diseases. The Lead Data Manager will be responsible for managing data management activities for clinical studies, ensuring high-quality data and compliance with regulatory standards while collaborating with cross-functional teams and vendors.
BiotechnologyMedical DevicePharmaceuticalBiopharma
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
Contribute to development and maintenance study-level Data Management Plans (DMPs), CRF completion guidelines, edit check specifications, and other data management documentation
Supports 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
Responsible for database lock planning and execution, including review of data listings and coordination of cross-functional deliverables
Coordinate with 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
Qualification
Required
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 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)
Benefits
Flexible paid time off
Medical
Dental
Vision and life/disability insurance
401(k) offerings (i.e., traditional, Roth, and employer match)
Supplemental life insurance
Legal services
Mental health benefits through our Employee Assistance Program for employees and their family
Company
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company developing therapeutics for the treatment of cardiovascular-metabolic diseases.
H1B Sponsorship
Madrigal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.94BKey Investors
Blue OwlHercules Capital
2025-07-22Post Ipo Debt· $350M
2024-03-18Post Ipo Equity· $690M
2023-09-28Post Ipo Equity· $500M
Recent News
2026-02-12
2026-02-12
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