SSO Study Start-Up Manager

Description

Summary: Responsible for planning, conducting, and interpreting clinical research and ensuring compliance with protocols and regulations. Highlights: 1. Oversees all operational activities of clinical trials 2. Expert in monitoring processes and systems 3. Creatively solves a broad range of problems ### **Summary** Planning, execution, and interpretation of clinical research, data collection activities, and clinical operations. Can communicate with study sites, clinical consultants, contract research organizations, and other vendors. Collaborates with local medical/clinical colleagues, global clinical teams, and oversees activities to execute and deliver assigned studies. Monitors patient data and study-related information regarding clinical research sites and participation in clinical trials. Ensures investigators adhere to study protocols, legal requirements, and good clinical practices, and provides input for the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, study files, and on-site visits, where applicable. Can oversee study sites and selection of audit facilities. ### **About the Role** Major Accountabilities \~ Is a global clinical specialist overseeing all operational activities, including planning, budgeting, implementation, and completion of clinical trials in accordance with local and international regulations. \~ Expert in monitoring processes, procedures, and systems. \~ Prepares and collects study site documents. \~ Conducts initiation visits and continues to train study staff as needed on study protocol, procedures, study drug handling and storage, etc. \~ Performs site closeout activities per SOP and applicable regulations. \~ Is a seasoned, experienced professional with full understanding of the area of specialization; creatively solves a broad range of problems. \~ Works on problems of varying scope \~ Networks with senior internal and external personnel within own discipline. \~ Contributes to many cost center objectives and goals; can contribute to service line objectives \~ May review 2010 Monitoring Visit Reports \~ Reports technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of samples for commercialization (if applicable) Key Performance Indicators Planning, execution, and interpretation of clinical research, data collection activities, and clinical operations. Can communicate with study sites, clinical consultants, contract research organizations, and other vendors. Collaborates with local medical/clinical colleagues, global clinical teams, and oversees activities to execute and deliver assigned studies. Monitors patient data and study-related information regarding clinical research sites and participation in clinical trials. Ensures investigators adhere to study protocols, legal requirements, and good clinical practices, and provides input for the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, study files, and on-site visits, where applicable. Can oversee study sites and selection of audit facilities. Work Experience \~People Leadership \~Operational management and execution \~Project management \~Cross-border collaboration \~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 Regular Shift Work No