SSO Study Start-Up Manager

Description

Summary: This role involves planning, executing, and interpreting clinical trial research, data collection activities, and clinical operations, with national and global collaboration. Highlights: 1. Supervises all operational activities of clinical trials. 2. Expert in process, procedure, and system control. 3. Experienced professional with comprehensive domain understanding. ### **Summary** Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. Can interact with trial sites, clinical consultants, contract research organizations, and other vendors. Collaborates with national medical/clinical colleagues, global clinical teams, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information pertaining to clinical trial sites and participation in clinical trials. Ensures investigator adherence to study protocols, regulatory requirements, and good clinical practices, and provides feedback in the data validation plan. Provides rapid and accurate monitoring of patient data and study-related information from source documents, research files, and on-site visits, as applicable. Monitors study sites and selection of audit facilities. ### **About the Role** Major Accountabilities \~ Is a global clinical specialist who supervises all operational activities—including planning, budgeting, implementation, and completion of clinical trials—in accordance with local and international regulatory requirements. \~ Expert in process, procedure, and system control. \~ Prepares and collects study site documents. \~ Conducts initiation visits and continues to train study staff, as needed, on study protocol, procedures, handling and storage of investigational medicinal products, etc. \~ Conducts site close-out activities per SOPs and applicable regulations. \~ Is an experienced and seasoned professional with comprehensive understanding of the specialization domain; creatively solves a broad range of problems. \~ Works on issues of diverse scope \~ Networks with senior internal and external personnel within own area of expertise. \~ Contributes to multiple cost center goals and objectives; may contribute to service line goals \~ May review and sign visit monitoring reports \~ Reports technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of marketing samples (if applicable) Key Performance Indicators Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. Can interact with trial sites, clinical consultants, contract research organizations, and other vendors. Collaborates with national medical/clinical colleagues, global clinical teams, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information pertaining to clinical trial sites and participation in clinical trials. Ensures investigator adherence to study protocols, regulatory requirements, and good clinical practices, and provides feedback in the data validation plan. Provides rapid and accurate monitoring of patient data and study-related information from source documents, research files, and on-site visits, as applicable. Monitors study sites and selection of audit facilities. Work Experience \~People Leadership \~Management and execution of operations \~Project management \~Collaborating across borders \~Crisis management Skills \~Clinical monitoring \~Clinical research \~Clinical trials \~Health sciences \~Clinical trial management systems \~Collaboration \~Data analysis \~Life sciences \~Clinical study reports \~Decision-making skills \~Budgeting \~Financial analysis Language English **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Division Development Business Unit Development Location Argentina Site Ramallo (Argentina) Company / Legal Entity AR01 (FCRS \= AR001\) Novartis Argentina S.A. Functional Area Research \& Development Job Type Full time Employment Type CDI Shift Work No