(sr.) Global Study Associate Manager - Cell Therapy

Trzdev35

Clinical study delivery oversight
External service provider management
Ich/gcp international guidelines knowledge
The Global Study Associate Manager provides oversight to ensure study delivery in partnership with internal and external stakeholders

Job Summary

  • The Global Study Associate Manager provides oversight to ensure study delivery in partnership with internal and external stakeholders.
  • They contribute to preparation of study documents, risk identification and mitigation, and support budget management and project management activities.
  • The role requires adherence to global clinical processes and guidelines to ensure the study is inspection ready at all times.

Matching Summary

The Global Study Associate Manager provides oversight to ensure study delivery in partnership with internal and external stakeholders.

Skills & Requirements

Must-have

  • clinical study delivery oversight
  • external service provider management
  • ICH/GCP international guidelines knowledge
  • project management skills
  • clinical study lifecycle experience
  • risk and issue mitigation
  • trial master file quality assurance

Nice-to-have

  • leadership skills
  • collaboration and independent work
  • advanced computer proficiency
  • communication and relationship building
  • process improvement leadership

Key Requirements

  • University degree in medical or biological sciences
  • At least 3 years pharmaceutical or clinical research experience
  • Knowledge of clinical development phases and therapy areas
  • Excellent English verbal and written communication
  • Basic knowledge of GXP beyond GCP
  • Experience managing CROs
  • Compliance with ICH/GCP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter