Perform assigned activities to monitor the investigator sites and trial execution within the CPO. Central point of communication between Novartis and Investigators for all clinical trial related activities to assure trials are conducted on time in compliance with GCP, ICH and Novartis SOP compliant.
1. Participated in the process of identification and selection of investigators in collaboration with clinical project leader.
2. Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators.
3. Facilitate preparation and collection of site level documents, especially ensure all document collected prior to study initiation.
4. Execute site initiation and training activities. 5. Perform monitoring visits according to monitoring plan. 6. Manage site drug supply management.
7. Resolve site level update of technical systems. 8. Ensure site activities in line with milestones ( i.e. Startup, recruitment, closeout, etc.
9. Manage recruitment implementing appropriate contingency plans at site level in collaboration with clinical project leader.
10. Managing center specific master file, and ensure investigator file completed as required. 11. Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.
12. Author study monitoring reports / contract report. 13. Perform data query resolution process (both at Site and with Data Management) 14.
Execute site closeout activities. 15. May act as local clinical project leader, as assigned. Perform assigned activities to monitor the investigator sites and trial execution within the CPO.
Central point of communication between Novartis and Investigators for all clinical trial related activities to assure trials are conducted on time in compliance with GCP, ICH and Novartis SOP compliant.
A Degree in scientific or health discipline required and advanced degree preferable. Fluent in English & local language (Oral and written) 1.
Basic medical and business knowledge. 2. desired 2+ years’ experience in clinical research or having demonstrated adequate level of proficiency within the CRA I or II competency profile.
3. Understands and can apply knowledge of clinical trial designs to trial execution. 4. Basic understanding and experience in clinical development process including international standards (GCP / ICH), and local regulations.
5. Expertise in communication, managing multiple priorities and computer literacy.