Pfizer Belgium
Manager, Senior Clinical Data Scientist, Clinical Data Sciences
Pfizer Belgium, Cambridge, Massachusetts, us, 02140
Pfizer - Manager, Senior Clinical Data Scientist, Clinical Data Sciences in Cambridge, Massachusetts
Why Patients Need YouPfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Our mission is simple: empower healthcare decisions regarding the safe and appropriate use of medicines for patients.What You Will AchieveYou 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 and validation activities.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. You will also work towards advancing new concepts and methodologies and 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.Serve as a technical resource to the study teams for data visualization and reporting tools.Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review, 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 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 trialsWorking knowledge of clinical research, FDA & GCDMP, and related regulatory requirementsStrong Project and Risk Management skillsStrong verbal and written communication skillsKnowledge of Windows Environment and its applications.Nice-to-HaveContract Research Organization (CRO) and vendor oversight experienceProficient in using commercial clinical data management systems and/or EDC productsPHYSICAL/MENTAL REQUIREMENTSNo specific requirements.Work Location Assignment: Remote
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Why Patients Need YouPfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Our mission is simple: empower healthcare decisions regarding the safe and appropriate use of medicines for patients.What You Will AchieveYou 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 and validation activities.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. You will also work towards advancing new concepts and methodologies and 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.Serve as a technical resource to the study teams for data visualization and reporting tools.Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review, 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 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 trialsWorking knowledge of clinical research, FDA & GCDMP, and related regulatory requirementsStrong Project and Risk Management skillsStrong verbal and written communication skillsKnowledge of Windows Environment and its applications.Nice-to-HaveContract Research Organization (CRO) and vendor oversight experienceProficient in using commercial clinical data management systems and/or EDC productsPHYSICAL/MENTAL REQUIREMENTSNo specific requirements.Work Location Assignment: Remote
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