Lead Data Manager

Madrigal Pharmaceuticals•Conshohocken, PA

48d•$144,000 - $176,000

About The Position

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 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.

Requirements

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).

Nice To Haves

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).

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.