Posted: Sunday, September 3, 2017 3:40 AM
The Clinical Project Manager (CPM) will lead and manage the 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.CPM at Director level will be accountable for developing the operational strategy and managing the timelines, budgets and quality of large or complex studies or a small /moderately sized program. This includes understanding and planning how different studies fit together (eg how the readout from a study informs the next steps and overall program strategy). It may also include planning and oversight of strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.May be required to provide supervision to other CPMs within a program.Cross-functional team leadership of clinical trial delivery:Single point of accountability for delivery from vendor selection through CSR/submissionAccountable for managing overall study timelines, budgets and quality targets for an individual protocol / programAbility to lead and manage in an ambiguous, dynamic environmentResponsible for cross-functional team communication and effectivenessDevelop and maintain positive team dynamics and healthDisciplined project and risk management approachOverall operational responsibility of clinical trial from study concept in development planning to submission/defenseProvides operational strategy for program/protocol developmentProvides high quality study information to support timely decision makingAccountable for building, forecasting and managing the Clinical Trial Budget for the programDrive operational delivery at the study level and across studies:Establish and charter the study teamLead the study team in achieving goals & milestones manages, facilitates and documents core study team meetings (eg meeting agendas & minutes, action logs and decision logs)Accountable for delivery to improved cycle times metricsFacilitate effective decision makingLead the team in managing issues and problem solvingDemonstrate Leader Behaviors in motivating and supporting the study teamEnsures execution against study/ program planManage critical changes and/or variance in financial forecast, schedule scope and deliverablesLeads the study team to manage risk mitigation strategies including:Identifying study level opportunities and risksPreparing, maintaining and implementing risk mitigation and contingency plansEnsures progression of SQEs and resolutionsEnsures cross-functional awareness, buy-in and agreement to risk/opportunities, action plans and resolutionEnsures all key stakeholders / senior management are informed of study/program level major risks/opportunities and corresponding contingency /mitigation plans.Ensures communication and integration of study level risks/opportunities at the program levelResponsible for coordinating, managing and maintaining Inspection Readiness documents according to GSOP requirements (maintaining Study Team Roster, Vendor List, Systems List, Decision Log, SOP Log)May perform some program level work in addition to study level work, some additional responsibilities may 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 programsLead clinical operations' sub-team(s) where appropriate, eg for large programs with multiple studies, in accordance with the organizational expectations and asset team charterDefine 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 opportunitiesEstablish and ensure adherence to operational standards and best practices for the asset or programLead the Operations Strategy including the Clinical Operations Plan along with the Sourcing/Vendor StrategyManage and deliver to timelines, budget and quality for all studies in a programInterface with the GCL and program level roles including at the CROParticipate in program level feasibility & country strategyAttend and represent Clinical Operations at governance meetings (including co-development studies)Manage & support escalationsDevelop and lead execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, rapid response. Manage other submissions activities as necessarySupport planning and technical review of licensing opportunities and/or due diligence activities. Oversee strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.Monitor progress against plan; develop and implement formal operational risk management plans across the asset/programCommunicate opportunities and risks to the category leadership. Ensures cross functional buy-in to risk mitigation plans and asset team's proposals for governance endorsement appropriately capture operational inputs and risksDefine and execute operational transition from early to late phase development and for the in-licensing and acquisition opportunitiesRepresent CD&O on the operationally-focused co-development teams with another development partner(s), where applicableTraining and Education:Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of GCPs, monitoring, clinical and regulatory operationsBS - minimum of 10 years relevant experienceMS/PhD - minimum of 8 years relevant experiencePrior Experience Preferred:Broad experience in a Clinical Trial Execution discipline (eg senior study management expertise, lead data management expertise, clinical leadership expertise)Demonstrated project management / leadership experienceExperience in understanding of key drivers impacting budgetsExperience in building a CTB and managing project to budgetSkills:Ability to lead cross-functional teams, identify, resolve & escalate issuesAbility to represent & communicate clearly at GovernancesAbility 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 experienceUnderstands interplay/intricacies of drug development programUnderstands how studies fit together and planning involved (sees the big picture)Broad project management experienceStrategic thinking and targeted problem solving skillsMaintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level managementStrong interpersonal skillsAdditional Details:Eligible for Employee Referral BonusCan be remote basedGrade 15Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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• Post ID: 131624007 nyother