Associate Clinical Trial Manager

Associate Clinical Trial Manager

Company Name: Madrigal Pharmaceuticals

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Department:

Research and Development

Location:

Hybrid, 3 days a week in Conshohocken office

About Madrigal

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Madrigal is actively expanding its clinical development organization to support ongoing late-stage trials and advance its growing pipeline of innovative therapies.

Position Responsibilities

The Associate Clinical Trial Manager (Associate CTM) will provide essential operational support in the planning, execution, and oversight of clinical trials. This role will work closely with the Clinical Trial Manager and cross-functional study teams to ensure study timelines, deliverables, quality, and compliance are maintained. The Associate CTM will assist in investigative site feasibility assessment, vendor coordination, document review, TMF management, and site support. This is an ideal opportunity for a high-performing clinical operations professional ready to take on increased responsibility in a collaborative and fast-paced environment.

Key Responsibilities

Study Operations Support

• Assist in day-to-day trial management activities to ensure study conduct aligns with the protocol, GCP, and SOPs
• Track and manage study milestones, enrollment metrics, and key performance indicators
• Coordinate logistics and support for investigator meetings, monitoring visits, and vendor interactions

Vendor and CRO Coordination

• Support Clinical Trial Manager in oversight of CROs, central labs, and other study vendors Review and track CRO and vendor deliverables such as visit reports, data listings, and site communications
• Assist in preparation and review of study-specific plans (e.g., monitoring plans, vendor manuals, vendor oversight plans)

Documentation and TMF Maintenance

• Ensure timely filing and quality control of essential study documents in the Trial Master File (TMF)
• Support audit readiness by helping maintain documentation compliance and version control
• Assist in the development and review of study manuals, trackers, and operational tools

Site and Clinical Team Communication

• Serve as a point of contact for study sites, addressing questions and escalating issues as appropriate
• Assist in preparation of meeting agendas, minutes, and study team communications
• Coordinate cross-functional input to resolve operational issues quickly and efficiently

Experience And Professional Qualifications

The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company:

• 3–5 years of experience in clinical research, clinical operations, or trial coordination, preferably in a biotech or pharmaceutical setting
• Experience working with CROs, ancillary vendors, TMFs, and clinical tracking tools
• Familiarity with clinical systems (CTMS, EDC, eTMF) is a plus
• Prior experience supporting global Phase 2 or Phase 3 trials preferred

Critical Competencies for Success

The Ideal Candidate Displays The Following Professional Competencies

• Strong understanding of clinical trial operations and GCP guidelines
• Excellent attention to detail and organizational skills
• Proactive problem-solver with strong time management
• Effective communicator with ability to coordinate across functions and vendors
• Adaptable and collaborative in a fast-paced, evolving environment

Education & Experience

• Bachelor’s degree in life sciences, nursing, public health, or related field required
• Advanced degree (MS, MPH, or equivalent) is a plus

Compensation:

Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

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.