Bristol Myers Squibb Clinical Site Manager in Shanghai, China
Manages the protocol execution at hub level. Coordinates and maintains effective communication with sites upon request and could be a contact for investigators when necessary. Provides feedback and status updates to internal stakeholders on an ongoing basis. Demonstrates an understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Work closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level. Independently monitors study progress by providing guidance as required and by close collaboration with other key stakeholders as applicable. Document substantive contacts concisely and in accordance with SOPs. Keeps awareness of site level issues from SMNs, identifies potential issues at protocol level and suggests resolutions. Answers and resolves routine or site related questions independently. Knows when to defer difficult or unresolved issues to the appropriate team member. Communicates information and issues to team and stakeholders to ensure that site management activities, protocol executions and study documentation are in compliance with study timelines. ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations. Provides ongoing training and mentoring to team members through a mentoring process using informal and/or formal presentations. Serve as a resource for colleagues. Understands how the issues of a single study can impact the overall project and contributes to establishment of best practice through coaching and feedback. Adapts well to ambiguous and complex work environment, balancing multiple priorities. Able to multi task, manage time and prioritize effectively. Co-monitors sites or conducts site visits independently as required and requested. Reviews Visit reports and takes action within the timelines specified and escalates issues appropriately
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