GMO Country Head

Major Responsibilities：

• Hire and supervise a team of CRM/CRA/CRS/CPM in cooperation with Country Oncology Medical Director.
• Assure that required level of knowledge and skill is present and trials sites are
• Further develop performance of country by identifying and screening new sites for participation in assigned clinical trials. Develop sites with outstanding potential for recruitment. Strengthen relationship with existing sites, build competitive advantage by establishing Novartis Oncology as a preferred partner for investigators.
• Set and meet specific targets for clinical trial budget and patient recruitment. Report on status of actual vs planned recruitment from all centers participating in trials in the area/country.
• Develop and implement local strategies to cut study start-up time. Monitor status of planned versus actual patient recruitment and take action to correct deviations from plan. Develop and implement strategies to ensure that investigative sites enter and clean data in a timely fashion and that data is collected in the most expedited fashion. Support monitors in resolving site level problems when and where needed.
• Provide close oversight and support of CRO activities in the country ensuring that the same project time lines and quality targets are met as for in-house trials
• Ensure that trial information is accurately and in a timely fashion entered into applicable project management and reporting systems. Provide additional trial status information as requested by Global Oncology Development and Country Oncology Medical Director.
• Ensure that all applicable legal, GCP and SOP requirements are met. Support the preparation and conduct of audits.
• Work closely with global clinical operations as well as global and local clinical teams to ensure a smooth launch, execution and close-out of clinical trials
• Work closely with Country Oncology Medical Director concerning study allocation and center selection. Communicate with local Medical Scientific Liaison functions on trial sites and enrollment status.

Requirement：

• 3-4 years experience in Oncology with established contacts in the medical community.
• At least 6 years experience in clinical development with proven proficiency in trial execution.
• Excellent site management capabilities with demonstrated  negotiating and problem solving skills
• Expert knowledge of GCP/ICH rules, international (FDA, EMEA) and local regulations as well as Novartis standards.
• Established track record of leading successful teams
• Experience in working in international teams
• Strong communicator and proactive approach