European Study Start-Up Lead

Biogen, Inc.; Maidenhead; Hybrid; GBP 70.000 - 90.000; Vollzeit

Zusammenfassung

Biogen, Inc. seeks a Regional Study Start-Up Lead to drive site activation across European countries, with deep EUCTR knowledge and hands-on start-up experience. The role requires coordinating SSU specialists, managing regulatory and site documentation, and ensuring on-time delivery of activation milestones.

Office presence in Baar, Switzerland is required three days per week. You will lead cross-functional teams, communicate activation strategies to country teams, and monitor progress to uphold

Qualifikationen

• Bachelor's degree in life sciences or equivalent required.
• Clinical trial experience, with regional start-up exposure and EUCTR familiarity.
• Experience in CRO environment and regulatory document submission within Europe.

Aufgaben

• Lead day-to-day management of multiple site activation projects across Europe.
• Drive site selection and activation within region to meet timelines and quality standards.
• Coordinate SSU specialists and ensure regional alignment with critical path plans.
• Ensure EC submission readiness and timely collection of ICFs, questionnaires, and related documents.
• Provide risk monitoring, metrics, and escalation handling to overseeing leadership.

Kenntnisse

Project management

Leadership

Stakeholder management

Cross-functional teams

Communication (English)

Ausbildung

Bachelor's Degree in life sciences or equivalent

Tools

CTMS

eTMF

Veeva

MS Project

Jobbeschreibung

Biogen, Inc. seeks a Regional Study Start-Up Lead to drive site activation across European countries, with deep EUCTR knowledge and hands-on start-up experience. The role requires coordinating SSU specialists, managing regulatory and site documentation, and ensuring on-time delivery of activation milestones.

Office presence in Baar, Switzerland is required three days per week. You will lead cross-functional teams, communicate activation strategies to country teams, and monitor progress to uphold