Overview
In this role you lead regional site activation initiatives to enable timely, compliant clinical trials. You will coordinate SSU activities across EUCTR and APAC, ensuring quality and on-time delivery while guiding country teams. You act as a subject-matter expert for EUCTR, manage regulatory and site-readiness workflows, and drive cross-functional collaboration. You contribute to Biogen’s mission by accelerating high-quality study start-up and enabling faster patient access to therapies. This position offers leadership across regions with impact on trial timelines and execution.
Verantwortungsbereiche
- Lead day-to-day management of multiple site activation projects or multi-study programs
- Drive regional site selection and activation to meet timelines
- Coordinate with SSU specialists to keep critical path on track
- Act as SME in EUCTR for timely collection of part 2 documents across overseen sites
- Manage EC submission strategy and regulatory payments within appropriate timeframes
- Oversee site activation readiness including site binders, training, and system access
- Provide quality checks of EC submissions and essential documents
- Escalate regulatory or vendor issues; provide risk-based mitigation
- Facilitate knowledge transfer across countries within regions
- Produce study progress reports and manage amendment implementations as needed
- Ensure consistent application of site activation processes across studies
- Collaborate with cross-regional leads to resolve activation issues
- Monitor and report risks to timelines to the Study Start-Up Oversight Lead
- Ensure timely ICF review and approvals across countries
Zentrale Anforderungen
- Bachelor’s degree in life sciences or equivalent
- Minimum 8 years of clinical trial experience
- At least 5 years in study start-up and 3+ years at a regional level
- Experience in CROs
- Strong EUCTR experience including submissions
- Start-up experience in APAC region
- Proven project management and site activation experience
- Excellent communication, organizational and leadership skills
- Proactive mindset with bottleneck identification and problem solving
- Ability to manage multiple projects in a matrix environment
- Strong English communication (listening, speaking, writing)
- Proficiency with CTMS, eTMF, Veeva, and Microsoft Project
- clear communication
- leadership
- proactive problem solving
- CTMS
- eTMF
- Veeva
Regional Study Start-Up Lead in Baar Arbeitgeber: Biogen Idec
Biogen ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einer dynamischen und innovativen Umgebung zu arbeiten, während Sie die globale Omnichannel-Transformation im Bereich Kundenengagement leiten. Unsere Unternehmenskultur fördert Zusammenarbeit und kontinuierliches Lernen, unterstützt durch umfassende Programme zur Mitarbeiterentwicklung und strategische Initiativen, die darauf abzielen, die Kundenbindung zu verbessern. Darüber hinaus profitieren Sie von einem flexiblen Arbeitsumfeld und der Chance, an vorderster Front der digitalen Transformation in der Biotechnologiebranche zu stehen.
