Clinical Study Manager

Takeda

Massachusetts, United States
Base: $103,500.00 - $162,690.00; bonus/equity: sho...
Fully remote
5+ years pharmaceutical industry experience
3+ years clinical study management oversight
Ich gcp and local regulatory knowledge
The role involves leading the operational strategy and execution of clinical studies for an assigned program while ensuring compliance with quality standards like ICH GCP

Job Summary

  • The role involves leading the operational strategy and execution of clinical studies for an assigned program while ensuring compliance with quality standards like ICH GCP.
  • Candidates will oversee strategic partners and CROs to meet obligations described in ICH-GCP and Takeda's business objectives within defined timelines and budgets.
  • Takeda offers a comprehensive benefits package including medical, dental, vision insurance, a 401(k) plan with company match, and up to 80 hours of sick time annually.

Matching Summary

The role involves leading the operational strategy and execution of clinical studies for an assigned program while ensuring compliance with quality standards like ICH GCP.

Salary

Base: $103,500.00 - $162,690.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time

Skills & Requirements

Must-have

  • 5+ years pharmaceutical industry experience
  • 3+ years clinical study management oversight
  • ICH GCP and local regulatory knowledge
  • Strategic partner and CRO vendor management
  • Study budget planning and financial accountability

Nice-to-have

  • Experience in multiple therapeutic areas
  • Early phase or Phase 2/3 global studies
  • Strong matrix leadership capabilities
  • Fluent business English communication skills

Key Requirements

  • BS/BA degree required
  • 5+ years pharmaceutical industry experience
  • 3+ years clinical study management experience
  • Knowledge of US CFR and EU CTD regulations

Work Rights

Not specified

Tailored Resume

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