Job Purpose: Central point of communication between Novartis and Investigators for all clinical trial related activities to assure trials are conducted on time andbudget, while fully GCP, ICH and Novartis SOP compliant. Compliance with applicable policies, procedures and other regulations.
Major Activities: 1.Participate /nominate new sites for clinical trials; perform evaluation of site capability and make recommendation for inclusion in clinical trial. 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. 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 (ClinAdmin, EDC). 8.Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc). 9.Manage recruitment implementing appropriate contingency plans as needed. 10.Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.) Resolve deviations to standard by remedial action and training. 11.Author study monitoring reports. 12.Perform data query resolution process (both at Site and with Data Management). 13.Execute site closeout activities. 14.May act as local (or global) CRA Lead, as assigned.
Key Performance Indicators 1.Delivery of high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations and Novartis SOP standards. 2.Feedback of external (investigators) and internal (TA/ BU) customers. 3. Refer to Annual performance target setting.
Ideal Backgrounds: Education: A degree in a scientific or health care discipline Languages: Fluent English (oral and written). Experience/Professional requirement: 1.Basic medical and business knowledge; 2.Understands and can apply knowledge of clinical trial designs to trial execution; 3.Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations; 4.Expertise in communication, managing multiple priorities and computer literacy.