上海招聘

Key Responsibilities:

• Demonstrate a strong leadership to effectively develop and execute clinical research with high quality in timeline and under budget.
• Manages and develops CPM group and start up team. Through effective management and development of direct reports, to ensures CPMs to successful deliver clinical research within the standards according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements.
• Oversee and optimize the procedure of all Clinical Study Projects and medical projects, make sure clinical study quality and efficiency and effectiveness
• Work closely with other functional team internally and external vendor to develop and train on new processes, best practice, and functional excellence initiatives.
• Close with quality function to ensure quality control and improvement
• Talent development and resource management to meet company’ needs

Key Activities:

• Management and oversight of clinical research and team’s performance
• Recruitment, on-boarding, development and mentoring of CPM and start up team
• Provides guidance to team member on study execution and delivery
• Supports and facilitates clinical study issue resolution
• Identifies successes, risks and action plans on study issues
• Initiate new activities or procedure in the company ensure efficiency and effectiveness such as start-up group implementation
• Drives continuous process improvement with focus on quality, cost, and time

Recommended Education and Key Competency:

Basic Qualifications

• Minimum Bachelor degree major in medical, biology, pharmacology or other life sciences subject
• Minimum 10 years of clinical operation experience including 6 years of project management on global studies and 2-3 years people management experience on PM;

Preferred Qualifications

• People management experience on CRA team
• Global pharmaceutical company and/or global CRO working experience

Knowledge

• Extensive knowledge of ICH/GCP regulations and guidelines
• Advanced knowledge of China clinical trial management including regulations and guidelines
• Clinical trial processes and operations
• Project and program management
• Time, cost and quality metrics
• Multiple Therapeutic Area knowledge

Key Competencies

• Project management
• People management
• Leadership skills including decision making, influence skills, stakeholder management
• Critical thinking and Problem solving
• Excellent organizational and planning skills
• Creative and innovative mindset, proactive working attitude
• Scientific/Technical excellence
• Ability to work effectively in a changing environment
• Language: Chinese & Business English fluency