临床项目经理PM(J10435)
3-3.8万北京市本科不限经验
职位描述
工作职责:
61 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).
61 Leads study team meetings.
61 Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.
61 Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.
61 Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.
61 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.
61 Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.
61 Provides oversight of CRO performance throughout study implementation.
61 Develops study training and may also coordinate/deliver training, as appropriate.
61 Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.
61 Manages and tracks trial enrollment.
61 Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.
61 Anticipates, manages, and escalates Issues as appropriate.
61 Maintains and archives at trial level documentation.
61 Partners with study team in the management of data locks (final and interim) and site closure.
任职资格:
61 Bachelor's degree in a scientific or health related field.
61 Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, NMPA regulations.
61 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.
61 Excellent verbal and written communication skills.
61 Excellent office computer skills, including experience with clinical databases.
61 Effective cross-functional team player with ability to work in a team environment.
61 Demonstrated leadership skills.
61 Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.
61 Experienced in serving on product development teams and understands the product development lifecycle.
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