职位描述:

• Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).

• Leads study team meetings.

• Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.

• Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.

• Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.

• Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.

• Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.

• Provides oversight of CRO performance throughout study implementation.

• Develops study training and may also coordinate/deliver training, as appropriate.

• Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.

• Manages and tracks trial enrollment.

• Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.

• Anticipates, manages, and escalates Issues as appropriate.

• Maintains and archives at trial level documentation.

• Partners with study team in the management of data locks (final and interim) and site closure

任职条件:

• Bachelor's degree in a scientific or health related field.

• Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, NMPA regulations.

• Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.

• Excellent verbal and written communication skills.

• Excellent office computer skills, including experience with clinical databases.

• Effective cross-functional team player with ability to work in a team environment.

• Demonstrated leadership skills.

• Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.

• Experienced in serving on product development teams and understands the product development lifecycle.