Manager of Clinical Trial Support

Major Responsibilities

• Supervise study administrative personnel (Clinical Support, Clinical trial assistant and Administrative Staff) in their day to day work. Establish clear direction and performance targets. Ensure process set-up, on-going tracking, and data analysis to identify issue and improve it.
• Attract and retain high performers. Build skills and knowledge of direct line reports. Coach, mentor, review progress, manage development needs and ensure that direct reports receive required training.
• Lead clinical support team to do some professional support for all studies in China, which includes but not limited to contracts management, sample exportation management
• Lead Clinical trial assistant to do administrative support for every study in China with close cooperation with Country lead monitor, which includes TMF management, payment management, investigator meeting management, support Country Lead Monitors do country management  task.
• Lead Administrative staff to do administrative training and compliance check for whole Monitoring and Site Management China team, and do external vendor management.
• Implement best practices and ensure quality management for study administrative support.
• Allocate resources to maximize efficiency and effectiveness based on priorities cascaded by the Local Head of Monitoring and Site Management in line with global Monitoring and Site Management Strategy. Match skills and capabilities of staff appropriately with the needs of the organization.

Requirement

• The incumbent must have a Bachelor’s degree or equivalent education with 5-7 years of relevant healthcare experience of which 3-5 years of Clinical Operations experience including clinical study support.
• Knowledge of clinical development, global Monitoring and Study Management processes, ICH-GCP, applicable legal and regulatory requirements. Leadership, motivational, and interpersonal skills are critical. Incumbent must possess the ability to lead staff in developing and applying new techniques as well as strong interpersonal skills in the management and development of staff. Administrative, financial, and technical skills are required, as well as effective verbal and written English communication skills in relation to both internal and external colleagues.