Regional Study Start-Up Lead

• 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 that you are overseeing.
• Ensure that all ECs and Regulatory authorities have been paid in an appropriate timeframe.
• Coordinate SSU specialists across regions and ensure all sites within regions are on track with the critical path site activation plan.
• Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.
• Monitor project status, identify risks, and provide metrics to the Study Start-up Oversight Lead.
• Ensure that Oversight Lead is aware of any risks to study timelines and develop appropriate mitigations.
• Facilitate knowledge transfers across countries within regions.
• Collaborate with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
• Oversee EC submission strategy and required documents: patient facing materials: ICFs, questionnaires, etc.
• Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
• Provide quality checks for EC submission packages for both central and local ECs.
• Provide quality checks of essential documents and essential document packages.
• Ensure operational readiness for site activation in collaboration with CML, including site binders, ancillary supplies, lab kits, training, and system access.
• Coordinate information flow between key stakeholders involved in site activation and ensure that the site activation form is signed off in a timely manner.
• Ensure consistency and application of processes within studies.
• Initiate and execute study-related progress reports.
• Provide oversight and management of amendment implementation as needed.

• Bachelor's Degree in life sciences or equivalent (e.g., pharmacy, nursing).
• 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.
• Haved worked in a study start-up group and have experience (specifically, ICF review experience, regulatory document review experience, and submission experience) managing startup for the European region.
• Previous experience in a Contract Research Organization (CRO) is essential.
• Strong EUCTR experience - previously involved in submissions.
• Proven experience in project management and site activation.
• Strong communication, organizational, and leadership skills.
• Proactive mindset with the ability to identify bottlenecks and propose solutions.
• Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment.
• Proven ability to handle a high volume of tasks of varying complexity and effectively utilize escalation pathways.
• Excellent communication skills (listening, oral, written) in English.
• Comfortable using CTMS, eTMF, Veeva, and Microsoft Project.

• Familiarity with regional regulatory processes and requirements.
• Experience in leading cross-functional teams effectively.
• Advanced proficiency in clinical trial management trackers and tools.

Job Level: Management Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.