公司部门: Clinical Development
• 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
• 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.