Associate Director, Tmf Operations

Systimmune Inc

Princeton, NJ, United States
$140,000 - $180,000 annually; not specified; 100% ...
On-site
Etmf system and process expertise
Vendor oversight
Inspection readiness and support
This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality

Job Summary

  • This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality.
  • Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics.
  • SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

Matching Summary

This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality.

Salary

$140,000 - $180,000 annually; Not specified; 100% paid employee premiums for medical/dental/vision, STD, LTD, 401(k) with 50% match up to 3%, 15 PTO days, 11 holidays

Skills & Requirements

Must-have

  • eTMF system and process expertise
  • vendor oversight
  • inspection readiness and support
  • ICH-GCP, DIA TMF Reference Model
  • clinical document management
  • eTMF system(s) training

Nice-to-have

  • fast-paced, evolving environment
  • limited structure
  • cutting-edge biologics development

Key Requirements

  • Bachelor's degree or equivalent experience
  • 10+ years clinical research experience
  • 5+ years TMF process management
  • Proficiency with eTMF systems and reporting
  • Experience with Veeva eTMF platform preferred

Work Rights

Not specified

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