SSO Study Start-Up Manager

Description

Summary: Responsible for planning, conducting, and interpreting clinical trials, as well as monitoring patient data and study-related information. Highlights: 1. Global monitoring and execution of clinical trials 2. Expertise in monitoring processes, procedures, and systems 3. Networking with senior internal and external colleagues ### **Summary** Planning, conducting, and interpreting clinical trials, research, data collection activities, and clinical operations. Can interact with investigative sites, clinical consultants, contract research organizations, and other vendors. Collaborates with local and global clinical teams of medical/clinical colleagues and leads activities to execute and conduct assigned studies. Monitors patient data and study-related information related to clinical trial sites and participation in clinical trials. Ensures that the investigator complies with research protocols, regulatory requirements, and good clinical practices, and contributes to the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and, where applicable, on-site visits. Can monitor study sites and selection of investigational facilities. ### **About the Role** Major Accountabilities \~ Serves as a global clinical specialist overseeing all operational activities—including planning, budgeting, conducting, and closing clinical trials—in compliance with local and international regulatory requirements. \~ Expert in monitoring processes, procedures, and systems. \~ Prepares and collects study site documents. \~ Conducts initiation visits and trains study staff, as needed, on study protocol, procedures, drug handling and storage, etc. \~ Conducts site closeout activities per SOPs and applicable regulations. \~ An experienced, seasoned professional with full subject-matter expertise; solves a variety of problems creatively. \~ Works on issues of varying scope \~ Networks with senior internal and external colleagues within the subject area. \~ Contributes to multiple cost center goals and objectives; may contribute to service-line goals \~ Can review and sign off monitoring visit 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, conducting, and interpreting clinical trials, research, data collection activities, and clinical operations. Can interact with investigative sites, clinical consultants, contract research organizations, and other vendors. Collaborates with local and global clinical teams of medical/clinical colleagues and leads activities to execute and conduct assigned studies. Monitors patient data and study-related information related to clinical trial sites and participation in clinical trials. Ensures that the investigator complies with research protocols, regulatory requirements, and good clinical practices, and contributes to the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and, where applicable, on-site visits. Can monitor study sites and selection of investigational facilities. Work Experience \~ Leadership skills \~ Operations 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 trial reporting \~ Decision-making skills \~ Budget \~ 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