Consultant Clinical Project Management
Company Name:
Eli Lilly
Job Description:
Responsibilities:
The CPM Consultant independently leads and has expertise in the implementation, application, and integration of standard clinical project management processes and tools. These project management processes and tools include but are not limited to the development, monitor, and control of integrated clinical scope, timelines, budgets, risk management plans, and communication plans. Other specific activities in this area include:
Independently manages either a) a substantive clinical program (e.g., a high cost and/or a high complexity clinical plan; or parallel development of multiple and/or novel indications) with substantive business impact, or b) a subset of an early phase therapeutic area portfolio.
Provides input on strategy for implementing the clinical plan, developing realistic project milestones and deliverables, and linking clinical plan to the intended label
Leads a team to develop and maintain appropriate clinical scope documentation; update clinical plan at least annually, or after major modifications in scope, resources or timeline and secure team/leadership alignment around the new clinical plan
Utilizes external inputs and ideas, leveraging business process knowledge to drive transformation within the function and cross-functionally
Develops and maintains up-to-date clinical plan timelines (using ProChain or Microsoft Project) and process maps (if appropriate)
Identifies, communicates and manages the critical path/chain and leading indicators of the teams progress to major clinical milestones
Monitors and reports performance to plan and drives team action when plan is not being achieved
Drives data completeness and accuracy within business systems by team, functions, and geographies
Partners with Financial, functions and geographies, to develop and manage the overall clinical budget for the team
Consults with Clinical Team to understand variances to the plan/forecast and reasons for the discrepancies.
Provides the team and leadership an understanding of the cost of development options
Leads assessment of clinical risks, mitigation/contingency planning and assignment of ownership.
Independently identifies and triggers when those plans should be implemented
Proactively identifies and communicates to the team the risks that may affect the clinical critical path and impact portfolio milestones, and proactively takes action to mitigate or avoid those risks.
Holds clinical risk owners accountable for monitoring and reporting status of risks; leads implementation of mitigation/contingency plans
Liaises with Medical Quality groups as escalation of issues occurs.
Leads the development, management, and communication of the clinical change control process and outcomes for team/project Influences and works with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics.
Drives clinical decisions to resolution.
Drives with cross-functional team members the planning and preparation of team clinical dossier specific documents. Serves as a point person for all clinical functional area deliverables related to the submission.
Provides critical evaluation of global submission strategy, including target countries.
Planning for clinical support of regulatory agency meetings and consultant or advisory board meetings.
Establishes and drives the overall clinical submission plan and timeline including critical path management, track progress against timeline, and drive resolution of issues to meet submission milestones
Responsible for planning and coordinating clinical activities in support of the regulatory approval process: regulatory response, 4-month safety update, label negotiations, and advisory committee preparations
Provides risks assessment on the clinical resource plan created by the Functional Manager/Team Leader
Proactively reviews project timelines, determines critical path and, by continually assessing any changes in peak workload, will notify the Medical Functional Manager/Team Leader of forecasted resource overloads that will affect critical path activities
Through conducting risk assessment and creating contingency plans for clinical projects, will immediately understand the impact of any resource roadblocks that may affect timelines
Assesses impact of clinical scope changes and provides recommendations to the team regarding the resource/budget implications of these changes
CPM Consultants will receive Level 3 Professional certification in Critical Chain Project Management and will be instrumental in driving the implementation of CCPM within their team and across the CPM function.
Basic
Qualifications:
Bachelors degree, preferably in a scientific or health-related field
At least 5 years of directly related clinical trial or pharmaceutical project management experience or relevant clinical development experience with a strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Additional Skills/Preferences:
Advanced degree and/or certifications (e.g., M.S., PMP)
Global clinical trial experience
Therapeutic experience
Experience in working with a non-Lilly business partner (e.g., CRO, Alliance , Joint Venture)
Demonstrated ability to work effectively cross-culturally and in a virtual work environment
Consistent demonstration of leadership behaviors and ability to influence others related to the consultant level
Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
Effective interpersonal and team building skills; proven ability to develop effective teams with diverse interpersonal styles; able to deliver effective coaching and feedback
Able to anticipate change, shows flexibility, adjusts quickly and effectively to frequent change and altered priorities
Strong computer skills; skilled at using Word, Excel, Powerpoint, and Microsoft Project; capable of maintaining the appropriate project documentation
Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team
Strong communication skills; able to communicate clearly and succinctly with team members and leadership
Ability to influence others without direct authority.
Must understand clinical drug development processes and the interdependencies of various tasks that require coordination among teams, functional groups, and regions
Demonstrated knowledge and experience with project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge)
Apply Online:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=9248BR&Codes=IMB
(Copy & Open the above link in a new page to apply for this job)Estimated Salary: $20 to $28 per hour based on qualifications.
Eli Lilly
Job Description:
Responsibilities:
The CPM Consultant independently leads and has expertise in the implementation, application, and integration of standard clinical project management processes and tools. These project management processes and tools include but are not limited to the development, monitor, and control of integrated clinical scope, timelines, budgets, risk management plans, and communication plans. Other specific activities in this area include:
Independently manages either a) a substantive clinical program (e.g., a high cost and/or a high complexity clinical plan; or parallel development of multiple and/or novel indications) with substantive business impact, or b) a subset of an early phase therapeutic area portfolio.
Provides input on strategy for implementing the clinical plan, developing realistic project milestones and deliverables, and linking clinical plan to the intended label
Leads a team to develop and maintain appropriate clinical scope documentation; update clinical plan at least annually, or after major modifications in scope, resources or timeline and secure team/leadership alignment around the new clinical plan
Utilizes external inputs and ideas, leveraging business process knowledge to drive transformation within the function and cross-functionally
Develops and maintains up-to-date clinical plan timelines (using ProChain or Microsoft Project) and process maps (if appropriate)
Identifies, communicates and manages the critical path/chain and leading indicators of the teams progress to major clinical milestones
Monitors and reports performance to plan and drives team action when plan is not being achieved
Drives data completeness and accuracy within business systems by team, functions, and geographies
Partners with Financial, functions and geographies, to develop and manage the overall clinical budget for the team
Consults with Clinical Team to understand variances to the plan/forecast and reasons for the discrepancies.
Provides the team and leadership an understanding of the cost of development options
Leads assessment of clinical risks, mitigation/contingency planning and assignment of ownership.
Independently identifies and triggers when those plans should be implemented
Proactively identifies and communicates to the team the risks that may affect the clinical critical path and impact portfolio milestones, and proactively takes action to mitigate or avoid those risks.
Holds clinical risk owners accountable for monitoring and reporting status of risks; leads implementation of mitigation/contingency plans
Liaises with Medical Quality groups as escalation of issues occurs.
Leads the development, management, and communication of the clinical change control process and outcomes for team/project Influences and works with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics.
Drives clinical decisions to resolution.
Drives with cross-functional team members the planning and preparation of team clinical dossier specific documents. Serves as a point person for all clinical functional area deliverables related to the submission.
Provides critical evaluation of global submission strategy, including target countries.
Planning for clinical support of regulatory agency meetings and consultant or advisory board meetings.
Establishes and drives the overall clinical submission plan and timeline including critical path management, track progress against timeline, and drive resolution of issues to meet submission milestones
Responsible for planning and coordinating clinical activities in support of the regulatory approval process: regulatory response, 4-month safety update, label negotiations, and advisory committee preparations
Provides risks assessment on the clinical resource plan created by the Functional Manager/Team Leader
Proactively reviews project timelines, determines critical path and, by continually assessing any changes in peak workload, will notify the Medical Functional Manager/Team Leader of forecasted resource overloads that will affect critical path activities
Through conducting risk assessment and creating contingency plans for clinical projects, will immediately understand the impact of any resource roadblocks that may affect timelines
Assesses impact of clinical scope changes and provides recommendations to the team regarding the resource/budget implications of these changes
CPM Consultants will receive Level 3 Professional certification in Critical Chain Project Management and will be instrumental in driving the implementation of CCPM within their team and across the CPM function.
Basic
Qualifications:
Bachelors degree, preferably in a scientific or health-related field
At least 5 years of directly related clinical trial or pharmaceutical project management experience or relevant clinical development experience with a strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Additional Skills/Preferences:
Advanced degree and/or certifications (e.g., M.S., PMP)
Global clinical trial experience
Therapeutic experience
Experience in working with a non-Lilly business partner (e.g., CRO, Alliance , Joint Venture)
Demonstrated ability to work effectively cross-culturally and in a virtual work environment
Consistent demonstration of leadership behaviors and ability to influence others related to the consultant level
Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
Effective interpersonal and team building skills; proven ability to develop effective teams with diverse interpersonal styles; able to deliver effective coaching and feedback
Able to anticipate change, shows flexibility, adjusts quickly and effectively to frequent change and altered priorities
Strong computer skills; skilled at using Word, Excel, Powerpoint, and Microsoft Project; capable of maintaining the appropriate project documentation
Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team
Strong communication skills; able to communicate clearly and succinctly with team members and leadership
Ability to influence others without direct authority.
Must understand clinical drug development processes and the interdependencies of various tasks that require coordination among teams, functional groups, and regions
Demonstrated knowledge and experience with project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge)
Apply Online:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=9248BR&Codes=IMB
(Copy & Open the above link in a new page to apply for this job)Estimated Salary: $20 to $28 per hour based on qualifications.
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