Major Accountabilities

1. Hire, train, supervise team of CRAs and allocate trials in assigned territory.

2. Assure that required level of knowledge and skill is present and trials sites are monitored as per SOPs. Identify skills and competency gaps. Work with training team to develop training plans and coordinate training as needed.

3. Develop territory by identifying and screening new sites for participation in assigned clinical trials.

4. Monitor on status of planned versus actual patient recruitment and implement strategies to correct deviations from proposed plan according to metrics. Ensure that project time lines and quality targets are met for all trials to support product registration/marketing support.

5. Ensure that prevailing legislation, GCP and SOP requirements are fulfilled.

6. Work to coordinate for audits.

7. Liaise with global TA/BU clinical teams (e.g. escalates unresolved site issues) and CPO colleagues to enhance Novartis relationship with clinical sites.

8. Manage and direct the monitors with problem solving at the site level where needed.

9. Set and meet specific targets for responsible clinical trial budget and patient recruitment

10. Provides operational input to Clinical Trial Protocols, CRFs and Data Management meetings as required

11. Sets objectives and conducts individual monitor’s performance reviews and makes salary recommendations

12. Leads, motivates and develops staff to improve and maintain their individual performance and that of their monitoring group as a whole

13. Provides training and coaching to CRAs with regard to all aspects of the drug development and clinical trial process

14. Coach and provide guidance to the staff to be compliant:

Ideal Background

Education: A degree in scientific or health discipline required

Languages: Fluent English (oral and written)

Experience: Expert in a specific disease area with established requirement: contacts in the medical community. At least 6 years experience in clinical research with proven proficiency in trial ution and drug development.