Central Monitoring Lead

Role Overview: You will be joining Astellas Pharma Inc., a global pharmaceutical company committed to developing innovative therapies for patients worldwide. As a Central Monitor at Astellas Global Capability Centres, you will play a crucial role in supporting drug development projects and ensuring the implementation of Risk Based Quality Management (RBQM) strategies. Your responsibilities will include collaborating with cross-functional study teams, conducting central monitoring activities, and overseeing the documentation and resolution of findings. Your expertise and leadership will contribute to the success of clinical trials and the advancement of medical solutions for patients. Key Responsibilities: - Facilitate the risk assessment process for study teams - Develop central monitoring plans based on study requirements - Identify critical data and Key Risk Indicators (KRIs) for centralized monitoring - Review statistical monitoring data outputs across sites, regions, and countries - Lead discussions on central monitoring observations with the clinical study team - Collaborate with study managers to address issues identified during centralized monitoring - Ensure proper documentation and storage of observations, investigations, and actions in Trial Master File - Contribute to optimizing centralized monitoring capabilities and processes - Participate in vendor evaluation and provide feedback on performance as needed Qualifications Required: - BS/BA degree in a biological science, statistics, health-related, or computer science field; advanced degree preferred - 7+ years of experience in pharmaceutical, clinical research, or health services industry - Minimum of 5 years of experience as a central monitor, clinical study manager, data manager, or biostatistician - Demonstrated data analytical and site monitoring skills in multiple development programs - Experience in multiple Therapeutic Areas or disease state/indications desired - Strong cross-functional understanding of clinical study management processes - Proficiency in computer systems including MS Word, MS Excel, MS PowerPoint, and MS Outlook - Excellent verbal and written communication skills - Ability to work with and influence individuals across multiple functions and disciplines Additional Details: Astellas is committed to equality of opportunity in all aspects of employment, including Disability/Protected Veterans.,