Senior TMF Operations Leader: Inspection Readiness

Regulatory Jobs; Conshohocken (Montgomery County); Sur place; USD 179 000 - 206 000; Plein temps

Avantages offerts par ce poste

Equity

Bonus

Benefits package

401(k)

Résumé du poste

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Associate Director TMF Operations will lead day-to-day TMF operational strategy, oversight, and inspector readiness across studies, ensuring documentation is complete, timely, and compliant with regulatory expectations.

This role manages FSP resources, drives quality, and partners with Clinical Operations, Quality, Regulatory, and vendors.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years in TMF/eTMF operations or clinical documentation.
• Experience overseeing FSP/CRO/vendor TMF activities.
• Strong knowledge of GCP, inspection readiness, sponsor oversight.
• Experience with eTMF systems; Veeva Vault preferred.
• Familiarity with CDISC TMF Reference Model.
• Experience developing TMF metrics and governance materials.
• Strong organizational and stakeholder management skills.
• Ability to manage competing priorities across studies.
• Inspection or health authority readiness experience.

Responsabilités

• Lead TMF operations to ensure complete, accurate, timely, and inspection-ready documentation.
• Oversee FSP TMF resources, performance, issue resolution, and risk escalation.
• Maintain TMF QC processes, sponsor QC review, sampling, and remediation follow-up.
• Monitor TMF health, metrics, and trends; drive corrective actions.
• Collaborate with Clinical Ops, Study Teams, Quality, Regulatory, and vendors.
• Support AI-enabled TMF workflows with appropriate human oversight.
• Identify continuous improvement opportunities across TMF operations and governance.

Connaissances

TMF operations

eTMF oversight

GCP knowledge

Vendor management

FSP/CRO oversight

Veeva Vault eTMF

CDISC TMF Reference Model

Regulatory compliance

Stakeholder management

Formation

Bachelor’s degree in life sciences or related field

Outils

Veeva Vault eTMF

Description du poste

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Associate Director TMF Operations will lead day-to-day TMF operational strategy, oversight, and inspector readiness across studies, ensuring documentation is complete, timely, and compliant with regulatory expectations.

This role manages FSP resources, drives quality, and partners with Clinical Operations, Quality, Regulatory, and vendors.