What You’ll Do: 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 EC’s 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 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: ICF’s, 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 ensuring that site activation form is signed off in a timely maner Ensure consistency and application of processes within studies. Initiate and execute study-related progress reports. Provide oversight and management of amendment implementation as needed.
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.
