TMF Operations Director - Inspection Readiness & Oversight

Madrigal Pharmaceuticals; Conshohocken (Montgomery County); On-site; USD 179,000 - 206,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits package

401(k) plan

Job summary

Madrigal Pharmaceuticals is seeking an Associate Director of TMF Operations to lead day-to-day TMF strategy, oversight, and inspection readiness across studies. You will manage FSP resources, ensure QA oversight, and drive metrics-driven governance with cross-functional teams.

The role requires strong TMF expertise, vendor oversight capability, and experience with eTMF systems, ideally Veeva Vault. Competitive salary and equity accompany comprehensive benefits.

Qualifications

• Bachelor’s degree required in life sciences, health sciences, clinical research, or related field.
• Strong experience in TMF operations, eTMF oversight, clinical documentation, clinical operations, or inspection readiness.
• Experience managing or overseeing FSP, CRO, or vendor-supported TMF activities.
• Strong knowledge of GCP, essential records, inspection readiness, sponsor oversight, and TMF health expectations.
• Experience with eTMF systems (Veeva Vault) preferred.
• Familiarity with the CDISC TMF Reference Model preferred.
• Experience developing or managing TMF metrics, QC processes, issue logs, remediation plans, and governance materials.
• Strong organizational, communication, escalation, and stakeholder management skills.
• Ability to manage competing priorities across studies, vendors, and internal stakeholders.
• Inspection/audit readiness experience preferred.

Responsibilities

• Lead TMF operations across assigned studies, programs, or enterprise TMF model to ensure complete, accurate, timely, inspection-ready documentation.
• Oversee FSP TMF resources, workload management, performance, issue resolution, quality review, and risk escalation.
• Establish and maintain TMF QC oversight processes, sponsor QC review, sampling strategy, quality issue tracking, and remediation follow-up.
• Monitor TMF health, timeliness, quality, and inspection readiness metrics to identify trends and corrective actions.
• Partner with cross-functional teams to ensure TMF expectations are understood and executed.
• Drive continuous improvement in TMF processes, governance, and vendor oversight.
• Support AI-enabled TMF workflows with appropriate human oversight.

Skills

TMF operations leadership

Inspection readiness

Sponsor oversight

FSP & vendor management

Quality issue management

Metrics & governance

Risk-based TMF review

Clinical documentation standards

Cross-functional communication

Operational discipline

Education

Bachelor’s degree in life sciences/related field

Tools

Veeva Vault eTMF

Job description

Madrigal Pharmaceuticals is seeking an Associate Director of TMF Operations to lead day-to-day TMF strategy, oversight, and inspection readiness across studies. You will manage FSP resources, ensure QA oversight, and drive metrics-driven governance with cross-functional teams.

The role requires strong TMF expertise, vendor oversight capability, and experience with eTMF systems, ideally Veeva Vault. Competitive salary and equity accompany comprehensive benefits.