Pfizer, S.A. de C.V
Manager, Senior Clinical Data Scientist, Clinical Data Sciences
Pfizer, S.A. de C.V, Pearl River, New York, United States, 10965
Manager, Senior Clinical Data Scientist, Clinical Data Sciences
United States - Washington – BothellUnited States - New York - Pearl RiverUnited States - Pennsylvania - CollegevilleUnited States - New York - New York CityUnited States - Massachusetts - CambridgeWe’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.What You Will AchieveIt is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc.As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.How You Will Achieve ItProvide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.Ensure work carried out by providers is in accordance with applicable Standard Operating Procedures (SOPs) and working practices.Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all Data Monitoring and Management (DMM) activities and interact with Clinical Data Scientist at study level for deliverables.Serve as a technical resource to the study teams for data visualization and reporting tools and provide technical expertise and business process support in technology systems.Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity and overall data management activities.Partner with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned.Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.Plan and execute communication plans and methods for engaging customer populations.QualificationsMust-HaveBachelor's Degree5+ years’ experienceExperience within the pharmaceutical industry or in a health information management roleWorking knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol reviewWorking knowledge of clinical research, Food and Drug Administration & International Conference on Harmonization Good Clinical Practices (GCDMP), and related regulatory requirementsStrong Project and Risk ManagementStrong verbal and written communication skills, demonstrated ability to handle multiple tasks and projectsKnowledge of Windows Environment and its applications.Nice-to-HaveMaster's degreeContract Research Organization (CRO) and vendor oversight experienceProficient in using commercial clinical data management systems and/or EDC productsPHYSICAL/MENTAL REQUIREMENTSNo specific requirementsWork Location Assignment: Remote
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United States - Washington – BothellUnited States - New York - Pearl RiverUnited States - Pennsylvania - CollegevilleUnited States - New York - New York CityUnited States - Massachusetts - CambridgeWe’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.What You Will AchieveIt is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc.As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.How You Will Achieve ItProvide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.Ensure work carried out by providers is in accordance with applicable Standard Operating Procedures (SOPs) and working practices.Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all Data Monitoring and Management (DMM) activities and interact with Clinical Data Scientist at study level for deliverables.Serve as a technical resource to the study teams for data visualization and reporting tools and provide technical expertise and business process support in technology systems.Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity and overall data management activities.Partner with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned.Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.Plan and execute communication plans and methods for engaging customer populations.QualificationsMust-HaveBachelor's Degree5+ years’ experienceExperience within the pharmaceutical industry or in a health information management roleWorking knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol reviewWorking knowledge of clinical research, Food and Drug Administration & International Conference on Harmonization Good Clinical Practices (GCDMP), and related regulatory requirementsStrong Project and Risk ManagementStrong verbal and written communication skills, demonstrated ability to handle multiple tasks and projectsKnowledge of Windows Environment and its applications.Nice-to-HaveMaster's degreeContract Research Organization (CRO) and vendor oversight experienceProficient in using commercial clinical data management systems and/or EDC productsPHYSICAL/MENTAL REQUIREMENTSNo specific requirementsWork Location Assignment: Remote
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