莆田招聘

工作职责:

Position Title:Senior Clinical Project Manager (Sr. CPM)

Line:Global Product Development (GPD) / Global Regulatory Affairs (GRA) / Development China (DC) / Clinical Trail Management (CTM)

Location:China

Role Summary:The Senior Clinical Project Manager (Sr. 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 in China. The Sr. 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) in China. The Sr. 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 Sr. 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.

Working at the program level as needed, accountable for developing the operational strategy and managing the timelines, budgets, and quality across all studies in the program in China. This includes understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy).

Organizational Relationships:

The Sr. CPM reports to the Clinical Operations Group Leader.

All core study team members (e.g. Clinician, Study Manager

Leads the cross-functional integration of all components of a study by working with study team members (including but not limited to Study Managers, Data Managers, Clinical Programmers, Medical Writers, Project Planners, Study Clinicians, Statisticians, Pharmaceutical Sciences, Regulatory, Clinical Quality Lead, Medical QA, finance manager, outsourcing lead) both internal and external to Pfizer to ensure studies deliver to agreed goals.

Partner with the Project Planners and Project portfolio managers to ensure accurate schedule, cost, resource management and controls are established and maintained between clinical study activities and the development plan.

Externally: Contract Resource Organization (CRO) Program Director (only for resourcing & issue resolution)

The Sr. CPM will champion operational excellence to provide continuous improvement of processes and sharing of best practices.

Resources Managed (budget and FTEs):

No direct reports

Matrix leader for core study team of 5-10 colleagues.

If working at program level as CPM Group Lead, provide oversight and coach to other CPMs.

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.

Additional responsibilities include on program level work:

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

Technical Competencies:Skills:

Ability to lead cross-functional teams, identify, resolve & escalate issues

Ability to represent & communicate clearly at Governances

Ability to understand and assimilate high-level data from all functions

If working at the program level in addition to the study level, additional capabilities & skills required

include:

Broad drug development experience

Understands interplay/intricacies of drug development program

Understands how studies fit together and planning involved (sees the big picture)

Broad project management experience

Strategic thinking and targeted problem solving skills

Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level management

Strong interpersonal skills

任职资格:

Qualifications (Training, Education & Prior Experience):Training and Education Preferred:

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 +10 years’ relevant experience

MS/PhD + 8 years’ relevant experience

Prior 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

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.