Clinical Trial Specialist

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 Trial Specialist (CTS) is a clinical operations professional who provides comprehensive administrative and operational support to the Clinical Operations team to ensure the successful execution of clinical trials in a rapidly growing biotechnology company. This role supports clinical trials across multiple phases and works closely with the Director of Clinical Operations, Clinical Trial Managers, CROs, vendors, and investigational sites. The CTS plays a supportive role in maintaining inspection-ready documentation in compliance with ICH-GCP, regulatory requirements, and company SOPs

Key Responsibilities

· Provide day-to-day operational support for multiple ongoing clinical trials (Phase I–IV) within a biotech setting.

· Support clinical trial start-up, conduct, and close-out activities.

· Review and/or create study documents (e.g. newsletters, and various study / site trackers)\

· Collaborate on the management and maintenance of the Trial Master File (TMF/eTMF) in accordance with ICH-GCP and internal SOPs.

· Review, collect, file, and quality-check essential documents from investigational sites, CROs, and vendors. Ensure accuracy and completeness.

· Ensure accurate version control and document completeness to help ensure inspection readiness.

· Support investigational site activation activities, including collection and review of regulatory documentation, as required.

· Coordinate communications with investigational sites, CROs, and vendors.

· Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites.

· Schedule and support internal and external study meetings; prepare agendas and meeting minutes.

· Assist with regulatory submissions, amendments, and ongoing maintenance activities.

· Support audit and inspection readiness activities, including document reconciliation and gap analysis.

· Assist with review and development of study documents and plans (e.g., Protocol, Informed Consent Form (ICF), vendor oversight plans, eCRF guidelines, IRT specifications, user manuals, etc.).

· Ensure compliance with applicable regulations, SOPs, and study plans.

· Maintain accurate data entry and tracking in CTMS, eTMF, and/or other clinical systems.

· May conduct UAT for EDC / IRT and data listing review of EDC data for analysis.

· Track investigator payments, contracts, and vendor invoices.

· Support CRO and vendor onboarding and ongoing oversight activities.

Required & Desired Qualifications

Competencies

· Solid understanding of clinical trial processes and ICH-GCP guidelines.

· Experience working closely with CROs and investigational sites.

· Experience supporting audits and regulatory inspections.

· Familiarity with FDA and global regulatory requirements.

· 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).

Educational Requirements

· Bachelor’s degree in life sciences, health sciences, or a related field or relevant work experience required.

· Minimum of 2-4 years of clinical trial experience

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.

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 $97,000 - $118,000 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. 

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. 

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. 

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. 

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. 

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.  

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.