TMF Operations Associate Director – Inspection Ready

Madrigal Pharmaceuticals, Inc.; Conshohocken (Montgomery County); Hybrid; USD 179,000 - 206,000; Full time

Benefits offered by this job

Equity

Bonus potential

401(k) with company match

Medical, dental, vision insurance

Paid time off

Employee Assistance Program

Job summary

Madrigal Pharmaceuticals, Inc. seeks an Associate Director of Trial Master File Operations to lead day-to-day TMF strategy and inspection readiness. You will own TMF quality, manage FSP resources, and align processes with regulatory expectations and CDISC TMF standards.

You'll partner across Clinical Operations, Quality, Regulatory, and vendors to ensure consistent TMF execution and timely issue remediation, contributing to a highly compliant trial ecosystem.

Qualifications

• Bachelor’s degree required; life sciences preferred.
• Strong TMF/eTMF operations and inspection readiness experience.
• Experience with FSP/CRO/vendor TMF activities and governance.

Responsibilities

• Lead TMF operations across studies or enterprise TMF model; ensure inspection-ready documentation.
• Oversee FSP TMF resources, workload, performance expectations, issue resolution, and risk escalation.
• Maintain TMF QC oversight processes, sponsor QC, sampling, and remediation follow-up.
• Monitor TMF health, metrics, and action plans; drive continuous improvement.

Skills

TMF operations

eTMF oversight

GCP knowledge

Vendor oversight

Inspection readiness

Clinical operations

Stakeholder management

Project management

Education

Bachelor's degree

Tools

Veeva Vault eTMF

CDISC TMF Reference Model

Job description

Madrigal Pharmaceuticals, Inc. seeks an Associate Director of Trial Master File Operations to lead day-to-day TMF strategy and inspection readiness. You will own TMF quality, manage FSP resources, and align processes with regulatory expectations and CDISC TMF standards.

You'll partner across Clinical Operations, Quality, Regulatory, and vendors to ensure consistent TMF execution and timely issue remediation, contributing to a highly compliant trial ecosystem.