1+ months

Sr. Clinical Project Manager

Pfizer
Hedgesville, WV 25427
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**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

+ L eads 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



**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



________________________________________________________________________

Employee's printed name Signature Date (dd/Mmm/yyyy)



________________________________________________________________________

Supervisor's printed name Signature Date (dd/Mmm/yyyy)



Signature if required



**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

+ L eads 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



**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



________________________________________________________________________

Employee's printed name Signature Date (dd/Mmm/yyyy)



________________________________________________________________________

Supervisor's printed name Signature Date (dd/Mmm/yyyy)



Signature if required



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical
Posted: 2020-01-06 Expires: 2020-04-09

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Sr. Clinical Project Manager

Pfizer
Hedgesville, WV 25427

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