SSO Study Start-Up Manager

Description

Summary: Planning, execution, and interpretation of clinical studies; interaction with research sites and other stakeholders; ensuring compliance with regulatory requirements. Highlights: 1. The clinic oversees all operational activities of clinical studies. 2. Expertise in monitoring processes, procedures, and systems. 3. An experienced professional who creatively solves a wide variety of problems. ### **Summary** Planning, execution, and interpretation of clinical studies, data collection activities, and clinical operations. May interact with research sites, clinical consultants, Contract Research Organizations, and other vendors. Guides activities to enable country medical/clinical colleagues to collaborate with global clinical teams and execute and present assigned studies. Monitors patient data related to clinical study areas and clinical study participation, as well as information related to the study. Ensures investigators’ compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP), and facilitates entry into the Data Validation Plan. Ensures timely and accurate tracking of patient data and study-related information from source documents, study records, and, where appropriate, field visits. May monitor study areas and audit facility selection. ### **About the Role** Major Accountabilities \~ A global clinical expert who oversees all operational activities, including planning, budgeting, implementation, and completion of clinical studies, in accordance with local and international regulatory requirements. \~ Expert in monitoring processes, procedures, and systems. \~ Prepare and collect study area documentation. \~ Conduct Initiation Visits and continue training study staff, as needed, on study protocol, procedures, study drug handling and storage, etc. \~ Conduct Site Close-Out activities per SOPs and applicable regulations. \~ An experienced professional with full mastery of the area of expertise; creatively solves a wide variety of problems. \~ Works on issues of varying scope. \~ Maintains senior internal and external networks within own area of expertise. \~ Contributes to multiple cost center goals and objectives; may contribute to service line goals. \~ Reviews and signs off on Monitoring Visit Reports. \~ Technical complaints / adverse events / special circumstance scenarios related to Novartis products must be reported within 24 hours of receipt. \~ Distribution of marketing samples (where applicable) Key Performance Indicators Planning, execution, and interpretation of clinical studies, data collection activities, and clinical operations. May interact with research sites, clinical consultants, Contract Research Organizations, and other vendors. Guides activities to enable country medical/clinical colleagues to collaborate with global clinical teams and execute and present assigned studies. Monitors patient data related to clinical study areas and clinical study participation, as well as information related to the study. Ensures investigators’ compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP), and facilitates entry into the Data Validation Plan. Ensures timely and accurate tracking of patient data and study-related information from source documents, study records, and, where appropriate, field visits. May monitor study areas and audit facility selection. Work Experience \~ Leading Teams \~ Operations Management and Implementation \~ Project Management \~ Cross-border Collaboration \~ Crisis Management Skills \~ Clinical Monitoring \~ Clinical Research \~ Clinical Research \~ Health Sciences \~ Clinical Research 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 Permanent Shift Work No