位于中华人民共和国的 8 个优质sr clinical study management职位（正在招聘！）

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Clinical Project Manager (Insourced to MNC)

Caidya -
上海市

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职位详情

完整职位描述

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Job Description:
Clinical Project Manager (Insourcing to one of the global MNC)

Main Responsibilities

Accountable for managing overall study timelines, budgets and quality targets
Accountable for building, forecasting and managing the Clinical Trial Budget
Leads the China core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
Ensures adequate China study team resources and leads study team chartering to ensure that study team structure, including sub-teams, are effective and efficient
Fosters optimal China study team health including formal team effectiveness assessments and action planning
Manages China study team communications to ensure cross-functional connectivity among study team members and supporting functional lines
Leads and oversees the study risk planning process (e.g. IQMP)
Oversees operational metrics across study and manages trends and escalations
Accountable for delivery to Best In Class metrics
Acts as a single, authoritative source of the study information and leads study level status reporting per organizational norms and expectations
Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log
Leads awareness and resolution of Significant Quality Events (SQEs) and escalations
Leads the study work order and change order processes
Ensures comprehensive operational input to protocol design
Monitors and remediates quality metrics and completes remediation tracker
Responsible for inspection readiness
Ensures Quality Gate timing planning, and team readiness
Responsible for obtaining requisite operational governance approvals per organizational norms and expectations.
Leads preparations and presents the study to operational governance
Provides clinical timelines, cost, and operational risk sections of the governance presentations, memos, and other materials used for decision making. Participate and may present assigned study (ies) in part or in full to technical and executive governance.
If taking on program level work in addition to study level work, additional responsibilities include:
Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs in China
Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter
Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities
Establish and ensure adherence to operational standards and best practices for the asset or program
Lead the Operations Strategy including the Clinical Operations Plan along with the Sourcing/Vendor Strategy
Manage and deliver to timelines, budget and quality for all studies in a program
Interface with the China Study Lead and program level roles including at the CRO
Participate in program level feasibility & country strategy
Attend and represent Clinical Operations at governance meetings (including co-development studies)
Manage & support escalations
Inspection management & readiness
Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program.

Qualification:

Extensive clinical trial conduct, clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
BS +8 years relevant experience
MS/PhD + 7 years’ relevant experience
Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
Demonstrated project management / leadership experience
Experience in understanding of key drivers impacting budgets
Experience in building a Clinical Trial Budget and managing project to budget

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在中华人民共和国的sr clinical study management个职位

Clinical Project Manager (Insourced to MNC)

Senior Clinical Data Manager

Senior Clinical Data Manager

Senior Talent Acquisition Specialist (China, remote)

Insourced Clinical Research Associate

Senior Clinical Research Associate, Beijing

Project Manager II/ Senior Project Manager (Early phase experience required)

Senior Statistical Programmer

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在中华人民共和国的sr clinical study management个职位

Senior Clinical Data Manager

Senior Clinical Data Manager

Senior Talent Acquisition Specialist (China, remote)

Insourced Clinical Research Associate

Senior Clinical Research Associate, Beijing

Project Manager II/ Senior Project Manager (Early phase experience required)

Senior Statistical Programmer

Related jobs to explore

我想收到关于 中华人民共和国 的 sr clinical study management 的最新职位提醒

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