SSO Study Start-Up Manager

Description

Job Summary: Responsible for the planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations, interacting with study sites, clinical consultants, CROs, and other vendors. Key Responsibilities: 1. Oversee all business activities, including planning, budgeting, execution, and completion of clinical trials. 2. Ensure investigators comply with the study protocol, regulatory requirements, and Good Clinical Practice (GCP). 3. Focus on professional monitoring of processes, procedures, and systems. ### **Summary** Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. May interact with study sites, clinical consultants, contract research organizations (CROs), and other vendors. Collaborates with national medical/clinical colleagues and the global clinical team, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information associated with clinical research sites and clinical trial participation. Ensures investigator compliance with the study protocol, regulatory requirements, and Good Clinical Practice (GCP), and provides input to data validation plans. Timely and accurate monitoring of patient data and study-related information from source documents, study records, and on-site visits (as applicable). May monitor study sites and review facility selection. ### **About the Role** Major Accountabilities \~ A global clinical expert responsible for overseeing all business activities—including planning, budgeting, execution, and completion of clinical trials—to meet local and international regulatory requirements. \~ An expert in monitoring processes, procedures, and systems. \~ Prepares and collects study site documentation. \~ Conducts initiation visits and provides ongoing training to site personnel on study protocols, procedures, drug handling, and storage, as needed. \~ Executes site close-out activities per SOPs and applicable regulations. \~ An experienced, seasoned professional with in-depth knowledge of the specialty area; solves broad-ranging problems in creative ways. \~ Handles issues of varying scope. \~ Maintains a network of senior internal and external professionals within their specialty area. \~ Contributes to multiple cost center goals and objectives; may help achieve service line goals. \~ May review and sign off on monitoring visit reports. \~ Reports technical complaints/adverse events/special circumstances related to Novartis products within 24 hours of receipt of Novartis products. \~ Distribution of marketing samples (if applicable) Key Performance Indicators Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. May interact with study sites, clinical consultants, contract research organizations (CROs), and other vendors. Collaborates with national medical/clinical colleagues and the global clinical team, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information associated with clinical research sites and clinical trial participation. Ensures investigator compliance with the study protocol, regulatory requirements, and Good Clinical Practice (GCP), and provides input to data validation plans. Timely and accurate monitoring of patient data and study-related information from source documents, study records, and on-site visits (as applicable). May monitor study sites and review facility selection. Work Experience \~ Leadership \~ Operations management and execution \~ Project management \~ Cross-functional 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 ability \~ 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