Clinical Project Manager

Description

Job Summary: This role focuses on the planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations, ensuring adherence to protocols and regulations. Key Highlights: 1. Expert in clinical trial monitoring processes and systems. 2. International collaboration with global clinical teams. 3. Creative problem-solving within the area of specialization. ### **Summary** Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. May interact with investigative sites, clinical consultants, contract research organizations, and other vendors. Collaborates with country medical/clinical colleagues, global clinical teams, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information associated with clinical study sites and participation in clinical trials. Ensures investigators adhere to research protocols, regulatory requirements, and Good Clinical Practice (GCP), and provides input into the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits as appropriate. May monitor study sites and select audit facilities. ### **About the Role** Major Accountabilities \~ A global clinical specialist overseeing all operational activities, including planning, budgeting, implementation, and completion of clinical trials in accordance with local and international regulatory requirements. \~ Expert in monitoring processes, procedures, and systems. \~ Prepare and collect study site documents. \~ Conduct initiation visits and continue training study staff as needed on study protocol, procedures, drug handling and storage, etc. \~ Perform site close-out activities per SOPs and applicable regulations. \~ An experienced professional with comprehensive understanding of the area of specialization; creatively resolves a wide range of problems. \~ Works on issues of diverse scope \~ Networks with senior internal and external personnel within own area of expertise. \~ Contributes to many cost center objectives and goals; may contribute to service line objectives \~ May review and sign off on monitoring visit reports \~ Notification of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of marketing samples (where applicable) Key Performance Indicators Planning, execution, and interpretation of clinical trial research, data collection activities, and clinical operations. May interact with investigative sites, clinical consultants, contract research organizations, and other vendors. Collaborates with country medical/clinical colleagues, global clinical teams, and leads activities to execute and deliver assigned studies. Monitors patient data and study-related information associated with clinical study sites and participation in clinical trials. Ensures investigators adhere to research protocols, regulatory requirements, and Good Clinical Practice (GCP), and provides input into the data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits as appropriate. May monitor study sites and select audit facilities. Work Experience \~ People Leadership \~ Operations Management and Execution \~ Project Management \~ International Collaboration \~ Crisis Management Skills \~ Clinical Monitoring \~ Clinical Research \~ Clinical Trials \~ Health Sciences \~ Clinical Trial Management Systems \~ Collaboration \~ Data Analysis \~ Biological Sciences \~ Clinical Study Reporting \~ 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