Country Study Manager

Roche UK

Warsaw, Poland
Non-interventional studies (nis)
Investigator-initiated studies (iis)
Real world evidence scientific programs
The Clinical Study Manager is a strategic and operational role within the Medical Cluster, accountable for providing local clinical operations expertise and leadership on assigned medical affairs projects and programs

Job Summary

  • The Clinical Study Manager is a strategic and operational role within the Medical Cluster, accountable for providing local clinical operations expertise and leadership on assigned medical affairs projects and programs.
  • This role also leads RACE (Review, Assess, Classify,Execute) classifying any type of data collection and supporting the squads.
  • Roche encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.

Matching Summary

The Clinical Study Manager is a strategic and operational role within the Medical Cluster, accountable for providing local clinical operations expertise and leadership on assigned medical affairs projects and programs.

Skills & Requirements

Must-have

  • Non-interventional studies (NIS)
  • Investigator-initiated studies (IIS)
  • Real World Evidence Scientific Programs
  • Compassionate Use Program (CUP)
  • Post Trial Access Program (PTAP)
  • ICH GCP/GVP/GPP adherence
  • Risk management activities

Nice-to-have

  • Personal expression and open dialogue
  • Thrive personally and professionally
  • Every voice matters culture
  • Flexibility to support business needs

Key Requirements

  • Project Management skills
  • Excellent written and verbal communication
  • Good knowledge of ICH GCP, GPP, Roche SOPs
  • Clinical development operational experience
  • Influencing and negotiation skills

Work Rights

Not specified

Tailored Resume

Cover Letter