Regional Clinical Start-Up Lead

Biogen, Inc.; Schweiz; Hybrid; EUR 129.000 - 193.000; Vollzeit

Zusammenfassung

Biogen, Inc. is seeking a Regional Study Start-Up Lead to manage site activation across EUCTR and APAC regions. You’ll drive site selection, oversee timelines, and coordinate with SSU specialists to ensure timely, compliant activations.

Strong communication and leadership are essential as you interact with country teams and regulators. The role requires extensive experience in study start-up, CRO environments, and proficiency with CTMS/eTMF tools, enabling effective management of multi-study

Qualifikationen

• Bachelor’s degree in life sciences or equivalent.
• Minimum of 8 years of clinical trial experience, with at least 5 years in a study start-up role and at least 3 at a regional level.
• Experience in a CRO and strong EUCTR submissions knowledge.
• APAC region start-up experience is essential.

Aufgaben

• Lead day-to-day management of multiple site-activation projects.
• Drive site selection and activation within your region.
• Ensure timelines and quality standards for EC/Regulatory submissions.
• Coordinate SSU specialists across regions and monitor critical path.
• Provide escalation support for regulatory or vendor issues.
• Communicate activation strategy to country teams and monitor progress.

Kenntnisse

EUCTR experience

APAC experience

Project management

Site activation

Cross-functional leadership

English communication

CTMS

eTMF

Veeva

Microsoft Project

Ausbildung

Bachelor’s Degree in life sciences or equivalent

Tools

CTMS

eTMF

Veeva

Microsoft Project

Jobbeschreibung

Biogen, Inc. is seeking a Regional Study Start-Up Lead to manage site activation across EUCTR and APAC regions. You’ll drive site selection, oversee timelines, and coordinate with SSU specialists to ensure timely, compliant activations.

Strong communication and leadership are essential as you interact with country teams and regulators. The role requires extensive experience in study start-up, CRO environments, and proficiency with CTMS/eTMF tools, enabling effective management of multi-study