The Center of Excellence will partnership with Quintiles business partners and leverage Quintiles global expertise, assist sites to become leading institutions in China for the conduct of clinical trials to international standards
Accountable for setting up the center of excellence function together with Chief Medical Officer (CMO) in Greater China region. Responsible for building, managing and developing site relationships at strategic levels in support of Greater China region.
Accountable for leverage Quintiles global team and regional team expertise to support key site development in Greater China.
RESPONSIBILITIES
• Strategic planning and development for key research centers in Greater China
• Set up the center of excellence function team by directly involved in staff recruiting and retention
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; Rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
• Key contact person with Quintiles global and regional function team to leverage their experience
• Responsible for building and developing site expertise through proactive identification and providing customized solutions to key sites
• Help CMO to maintain China Advisory Board
• Establish and maintain relationship with key medical associations in China
• Explore business opportunities through partner alliance with local pharmaceutical companies and other stakeholders
• Responsible for assisting the medical needs from key opinions leaders (KOL) such as protocol design and publications
• Serves as scientific advisor and provide guidance to KOLs on the medical and scientific aspects.
• Organize protocol design workshop/seminars
• Perform Training and needs analysis to identify, plan, develop and deliver ICH GCP training at sites
• Implement investigator training initiative across China
• Work together with Feasibility and Site ID team to ensure key sites are selected for assigned studies as appropriate
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Strong understanding of Clinical Development process.
• Strong understanding of ICH GCP
• Hands-on experience of medical affairs related tasks
• Effective time management skills and ability to manage competing priorities.
• Strong interpersonal and communication skills
• Fluent in written and spoken English..
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Medical degree from an accredited and nationally recognized medical school, plus a minimum of 5 years’ experience in clinical medicine, in addition to 2-3 years’ clinical development experience in the Pharma, CRO or Biotech companies.
PHYSICIAL REQUIREMENTS
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Occasional travel required
