Senior Manager, Tmf Operations (etmf / Veeva Vault)

Arrowhead Pharmaceuticals, Inc.

San Diego, United States
$140,000—$170,000 usd; not specified; excellent be...
On-site
Etmf process oversight
Veeva vault experience
Gcp and gdp compliance
The Senior Manager will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work and performing oversight to TMF metrics and trends

Job Summary

  • The Senior Manager will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work and performing oversight to TMF metrics and trends.
  • Responsibilities include ensuring GCP/SOP/WI training, providing leadership on eTMF study-related issues, and managing eTMF system administration functions.
  • The role requires a minimum of 8 years of relevant experience in clinical operations/quality, with a minimum of 2 years in a managerial or lead role and a minimum of 3 years in TMF experience.

Matching Summary

The Senior Manager will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work and performing oversight to TMF metrics and trends.

Salary

$140,000—$170,000 USD; Not specified; Excellent benefit package

Skills & Requirements

Must-have

  • eTMF process oversight
  • Veeva Vault experience
  • GCP and GDP compliance
  • TMF metrics and trends
  • vendor and CRO oversight

Nice-to-have

  • process improvement initiatives
  • cross-functional collaboration
  • industry compliance trends
  • risk-based quality management

Key Requirements

  • Minimum 8 years clinical operations/quality experience
  • Minimum 2 years managerial or lead role
  • Minimum 3 years TMF experience
  • Minimum 2 years Veeva eTMF management experience
  • Knowledge of US, EU, international regulatory standards

Work Rights

Authorization to work in the US

Tailored Resume

Cover Letter