Job Details

Clinical-Project-Manager-Associate-Dire

Company name
Pfizer Inc

Location
Des Moines, IA
10 hit(s)  

Profile

This role can be remote based or at one of the Pfizer R&D locations:Groton CT, NYC, Collegeville PA, La Jolla CA.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.If working at the program level, the CPM is accountable for developing the operational strategy and managing the timelines, budgets, and quality across all studies in the program. 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). 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.Responsibilities:Accountable for managing overall study timelines, budgets and quality targetsAccountable for building, forecasting and managing the Clinical Trial BudgetLeads the core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, actionlogs and decision logs) and facilitates effective decision makingEnsures adequate study team resources andleads study teamcharteringto ensure that study team structure, including sub-teams, areeffective and efficientFosters optimal study team health including formal team effectiveness assessments and action planningManages study team communications to ensure cross-functional connectivity among study team members and supporting functional linesLeadsand oversees the study risk planning process (e.g. IQMPOversees operational metrics across study and manages trends and escalationsAccountable for delivery to Best In Class metricsActs as a single, authoritative source ofthe study information andleads study level status reporting per organizational norms and expectationsEnsures maintenance and accuracy of Standard Operating Procedures (SOP) logLeads awareness andresolutionof Significant Quality Events (SQEs) and escalationsLeads the study work order and change order processesEnsures comprehensive operational input to protocol designMonitors and remediates quality metrics and completes remediation trackerResponsible for inspection readinessEnsures Quality Gate timing planning, and team readinessResponsible for obtaining requisite operational governance approvalsper organizational norms and expectations. Leads preparations and presents the study to operational governanceProvidesclinical 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)inpart or in full to technical and executive governance.If taking on program level work in addition to study level work, additional responsibilities include:Represent clinical operations on the asset levelteams as per the organizational expectations and asset teamcharter, serve as a single point of accountability for operational delivery of clinical programsLead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organ

Company Profile
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

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