职位描述

职位描述： The Clinical Project Manager (CPM) will lead and manage the core cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense.The CPM is an expert on the operational delivery of clinical trials and brings that expertise to the design &; conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPM will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets. The CPM is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.?Accountable for managing overall study timelines, budgets and quality targets?Accountable for building, forecasting and managing the Clinical Trial Budget?Leads the 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 study team resources (escalating to Asset team where required) and leads study team to ensure that study team structure, including sub-teams, are effective and efficient?Fosters optimal study team health including formal team effectiveness assessments and action planning?Manages 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 with support from Study Management for site level updates.?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 at a study level with site facing activities such as self-inspection remaining the responsibility of the Study Management group?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 and costs for feasibility scenario planning to support Asset Team decision making process?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.?The CPM will champion operational excellence to provide continuous improvement of processes and sharing of best practice?Partner with Project Planner and study team members to develop study level plans and processes to ensure alignment with overall Development Plan?Propose alternative study operation strategies to optimize the use of time, cost and resources.?Maintain and enhance knowledge in disease and technical areas and in global / China regulations/ guidelines pertaining to clinical trialsCPM:Skills:?Ability to lead cross-functional teams, identify, resolve &; escalate issues?Ability to represent &; communicate clearly at Governances including at the Global Level.?Ability to understand and assimilate high-level data from all functionsQualifications (Training, Education &; Prior Experience):Training and Education Preferred:?Extensive clinical trial conduct, global 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 operationsCPM?BS – minimum of 8 years relevant experience?MS/PhD – minimum of 5 years relevant experiencePrior Experience Preferred:?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 职能类别： 临床协调员

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