Clinical Data Coordinator

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 Data Coordinator is responsible for supporting the collection, management, and quality assurance of clinical trial data to ensure data integrity and regulatory compliance. This role works closely with Data Managers, Clinical Operations, Biostatistics, and external vendors to facilitate accurate and timely database delivery for Madrigal Pharmaceuticals’ clinical development programs. The Clinical Data Coordinator contributes to data entry tracking, query management, and data cleaning activities in alignment with Good Clinical Practice (GCP) and company standards.

Key Responsibilities
• Assist in the setup, maintenance, and closeout of clinical study databases across multiple phases of development.
• Support Data Managers in ensuring data accuracy, completeness, and consistency throughout the clinical trial lifecycle.
• Perform routine data entry checks, generate and track data queries, and ensure timely resolution in collaboration with site personnel and vendors.
• Participate in the review and testing of electronic data capture (EDC) systems, case report forms (CRFs), and data validation specifications.
• Track receipt and review of external data sources (e.g., laboratory, imaging, PK/PD, ECG, ePRO) to ensure timely integration and reconciliation.
• Assist in the preparation of Data Management Plans (DMPs), edit check specifications, and data validation listings.
• Maintain documentation of data cleaning activities, ensuring compliance with SOPs, GCP, and regulatory requirements.
• Participate in data review meetings and contribute to database lock readiness activities.
• Support audit and inspection preparation by ensuring documentation accuracy and traceability.
• Perform other related duties as assigned in support of departmental and corporate goals.

Qualifications and Experience
• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• Minimum of 1–2 years of experience in clinical data management or a related clinical research role within the pharmaceutical or biotechnology industry.
• Working knowledge of clinical trial processes and regulatory guidelines (GCP, ICH, FDA).
• Experience with one or more electronic data capture (EDC) systems such as Medidata Rave, Oracle InForm, or Veeva CDMS.
• Familiarity with clinical data standards (CDASH, SDTM) preferred.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work collaboratively in a hybrid team environment and manage multiple priorities.

Preferred Experience
• Exposure to complex or adaptive clinical trial designs.
• Experience supporting Phase II or III clinical trials.
• Familiarity with data from external vendors (e.g., central labs, imaging, ECG, ePRO, PK/PD).
• Experience in oncology, metabolic, or cardiovascular clinical trials preferred.
• Prior involvement in data reconciliation, SAE reconciliation, or data review listings generation.
 

Core Competencies
• Quality Focus: Demonstrates a commitment to maintaining high data quality and accuracy.
• Accountability: Takes ownership of assigned tasks and delivers results in a timely manner.
• Collaboration: Works effectively with internal and external stakeholders in a team-oriented environment.
• Adaptability: Responds positively to changing priorities and timelines in a dynamic research setting.
• Integrity: Upholds ethical standards and maintains confidentiality of clinical data.

Madrigal’s Total R