Regional Study Start-Up Lead

BiogenBaar, SwitzerlandonsiteSalary not postedView the original posting at Biogen ↗

Job Title: Regional Study Start-Up Lead About This Role: As a Regional Study Start-Up Lead, you will play a pivotal role in managing the effective delivery of site activation for European countries. For this particular role you will be required to have expert knowledge in EUCTR and hands on study start up experience within the European region. This position is crucial in overseeing site activation according to prescribed timelines and quality standards, while coordinating closely with SSU Specialists. You will be responsible for managing technical and operational aspects to ensure successful site selection and activation. Your leadership will be instrumental in driving site selection efforts, communicating strategies to country teams, and monitoring progress to maintain alignment with business goals. By spearheading these initiatives, you contribute significantly to our overarching mission of delivering high-quality clinical trials and advancing healthcare solutions. It is required to work in the Baar, Switzerland office 3 days a week. 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 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. Who You Are: You thrive in dynamic environments, demonstrating an ability to manage multiple projects and coordinate cross-functional teams with ease. Your strong communication and leadership skills enable you to effectively influence stakeholders and drive results. You possess a proactive mindset, always looking to identify bottlenecks and propose innovative solutions. Your experience working in study start-up roles at a regional level on clinical trials equips you with the expertise needed to navigate complex challenges. You are detail-oriented and adept at handling a high volume of tasks, ensuring that priorities are met in a timely manner. Required Skills: 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

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