Clinical Site Manager 临床项目经理 - 上海/北京

Job responsibility:
Manages the protocol execution at hub level. Coordinates an********effective communication with sites upon request an******** be a contactfor investigators when necessary. Provides feedback an******** updatesto internal stakeholders on an ongoing basis. Demonstrates anunderstanding of the overall project goals, the indicationstudie******** the purpose of the assigne******** in meeting theobjectives of the project. Work closely with other study team members inthe coordination of study activities to meet the appropriate timelinesat the site/protocol level. Independently monitors study progress byproviding guidance as require******** by close collaboration with otherkey stakeholders as applicable. Document substantive contacts conciselyan******** accordance with SOPs. Keeps awareness of site level issuesfrom SMNs, identifies potential issues at protocol level an********resolutions. Answers an******** routine or site relate********independently. Knows when to defer difficult or unresolve******** to theappropriate team member. Communicates information an******** to teaman******** to ensure that site management act******** protocolexecutions an******** documentation are in compliance with studytimelines. ICH-GCP gu******** SOPs an******** regulatory guidelines orregulations. Provides ongoing training an******** to team membersthrough a mentoring process using informal and/or formal presentations.Serve as a resource for colleagues. Understands how the issues of asingle study can impact the overall project an******** to establishmentof best practice through coaching an********. Adapts well to ambiguousan******** work env******** balancing multiple priorities. Able tomult********, manage time an******** effectively. Co-monitors sites orconducts site visits independently as require******** requested.Reviews Visit reports an******** action within the timelinesspecifie******** escalates issues appropriately.

Job requiremen********
Knowledge equivalent to that attaine******** a Bachelor’s degree inClinical Me******** Pharmacy, Nursing an******** relate******** relevantexperience.
Thorough understanding of ICH-GCP gu******** China GCP guidelinesan******** Regulatory guidelines Knowledge of general clinical researchincluding investigator site ******** important milestones an******** toensure timelines are met.
Knowledge of the pharmaceutical industry an******** the pre-cl********cl******** regulatory an******** components.
Experience Desired:
Experience as an Lea********(Monitor)/ Senior CRA (Monitor) orequivalent experience within the pharmaceutical industry.
Experience with aspects of project management.
Experience in the conduct an******** of Investigator sites from start-upto database lock within expectations set by management.
Experience working in a team environment within a matrix organization.