Europe Study Start-Up Lead - EUCTR Expert

Biogen; Maidenhead; Hybrid; GBP 90.000 - 120.000; Vollzeit

Zusammenfassung

Biogen is seeking a Regional Study Start-Up Lead to drive site activation across European countries, with expert EUCTR knowledge and hands-on start-up experience. This role requires coordinating SSU specialists and ensuring timely, quality site activations across the region, including overseeing regulatory and EC submission processes.

You will lead cross-functional teams, manage timelines, and communicate activation strategies to country teams while maintaining alignment with business goals.

Qualifikationen

• Bachelor's Degree in life sciences or equivalent (e.g., pharmacy, nursing).
• Clinical trial experience, with solid experience in a study start-up role and at a regional level.
• Have worked in a study start-up group with ICF review, regulatory document review, and submission experience for the European region.
• Previous experience in a CRO is essential.
• Strong EUCTR experience – previously involved in submissions.
• Proven experience in project management and site activation.
• Excellent communication, organizational, and leadership skills.
• Proactive mindset with ability to identify bottlenecks and propose solutions.
• Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment.
• Excellent English communication (listening, oral, written).
• Comfortable using CTMS, eTMF, Veeva, and Microsoft Project.

Aufgaben

• Lead day-to-day management of multiple projects or a multi-study program for site activation.
• Drive site selection processes within your region to ensure timely and efficient activation.
• Oversee site activation according to timelines and quality standards across a region.
• Communicate site activation strategy to country teams and monitor progress.
• Act as a SME in EUCTR ensuring timely collection of part 2 documents for all countries and sites you oversee.
• Ensure ECs and Regulatory authorities have been paid in a timely manner.
• Coordinate SSU specialists across regions and ensure sites stay on the critical path.
• Escalate issues identified by SSU specialists including regulatory and vendor setup issues.
• Monitor project status, identify risks, and provide metrics to Study Start-up Oversight Lead.
• Ensure Oversight Lead is aware of risks and develop mitigations.
• Facilitate knowledge transfers across countries within regions.
• Collaborate with Regional/Oversight Leads to resolve issues and ensure adherence to plan.
• Oversee EC submission strategy and required documents: patient facing materials (ICFs, questionnaires).
• Manage country and site ICF timelines; review and approve country ICFs.
• Provide quality checks for EC submission packages and essential documents.
• Ensure operational readiness for site activation with CML, site binders, lab kits, training, and system access.
• Coordinate information flow among stakeholders and sign-off on site activation forms.
• Ensure consistency and application of processes within studies.
• Initiate and execute study-related progress reports.
• Provide oversight of amendment implementations as needed.

Kenntnisse

Bachelor's Degree in life sciences

Clinical trial experience

ICF review experience

Regulatory document review experience

Submission experience

CRO experience

EUCTR experience

Project management

Site activation

English communication

CTMS

eTMF

Veeva

Microsoft Project

Ausbildung

Bachelor's Degree in life sciences or equivalent

Tools

CTMS

eTMF

Veeva

Microsoft Project

Jobbeschreibung

Biogen is seeking a Regional Study Start-Up Lead to drive site activation across European countries, with expert EUCTR knowledge and hands-on start-up experience. This role requires coordinating SSU specialists and ensuring timely, quality site activations across the region, including overseeing regulatory and EC submission processes.

You will lead cross-functional teams, manage timelines, and communicate activation strategies to country teams while maintaining alignment with business goals.