Senior Clinical Trial Manager

Madrigal Pharmaceuticals • Conshohocken, PA

4d • $157,000 - $191,000

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 Senior Clinical Trial Manager supports the execution of clinical trials to ensure compliance with protocols, GCP, and regulatory requirements. The role supports study document development, investigator and site selection, and the identification and escalation of study, site, and vendor issues. Working closely with CROs, CRAs, data management, and vendors, this position ensures effective subject tracking, data quality and query resolution, investigational product accountability, budget and payment management, and timely trial progress reporting, while contributing to site initiation and monitoring activities and cross-functional collaboration.

Requirements

• Bachelor’s degree required and advanced degree (MS, MPH, PharmD, PhD) preferred.
• Minimum of 7-10 years of clinical trial experience.
• Experience supporting clinical trials across one or more phases (Phase I–IV).
• Experience working with CROs and/or external vendors.
• Experience in a biotech, pharmaceutical, or similarly dynamic environment preferred.
• Familiarity with the pace and cross-functional nature of a biotech environment.
• Strong organizational skills with exceptional attention to detail.
• Ability to work on multiple studies and manage multiple priorities.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Nice To Haves

• Exposure to early-phase or first-in-human studies a plus.
• Therapeutic experience in metabolic and/or cardiovascular clinical studies a plus.

Responsibilities

• Responsible for the preparation and finalization of project and study-related documents including: Informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, as required
• Responsible for assisting in the selection of investigators and study sites
• Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Clinical Operations Manager
• Collaborates with clinical trial managers from CRO to provide on-going tracking and reporting of subject information to help ensure that all subject screening and randomization proceed as planned and all other key study procedures are performed in accordance with the protocol.
• Collaborates with data management in the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
• Ensures that CRF data queries are resolved in collaboration with data management and CRAs
• Coordinates and manages Investigational Product including overall accountability and reconciliation
• Manages study budget and payment process for all clinical trial vendors including investigative sites
• Monitors and tracks clinical trial progress and provide status update reports
• Assists in the management of all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG) in collaboration with CRO and Clinical Operations Manager
• Assists in oversight of study CRAs (e.g., review of all trip reports) and provides guidance on site issues
• Participates in Site Initiation Visits (SIVs), as required
• Co-Monitors regional sites for adherence to protocol and GCP, as required
• Identifies and escalates site, vendor and study related issues to Clinical Operations Manager, as appropriate
• Participates in clinical and department settings, including attending additional meetings as required, and interacts in a positive and professional manner
• Performs other duties as assigned

Benefits

• Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
• Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
• 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.
• We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level