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Pfizer Inc. Clinical Data Scientist (Manager) in Boulder, Colorado

ROLE SUMMARYAs part of the Data Monitoring and Management group, an integral deliveryunit within the Global Product Development (GPD) organization, theClinical Data Scientist is responsible for timely and high quality datamanagement deliverables supporting the Pfizer portfolio. The Clinical DataScientist designs, develops, and maintainskey data management deliverablesused to collect, review, monitor, and ensure the integrity of clinicaldata, oversees application of standards, data review and querymanagement, and is accountable for quality study data set release andconsistency in asset/submission data.ROLE RESPONSIBILITIESServe as Clinical Data Scientist for one or more clinical trials assumingresponsibility for all DMandM activities including selection and applicationof data acquisition standards, Data Management Plan, selection of qualityrisk indicators, third party study data due diligenceParticipates and ensures quality database design including documentation,testing and implementation of clinical data collection tools, both CRF andnon-CRF, using an electronic data capture (EDC) system and/or otherdata collection systems.Serve as a technical resource to the study teams for DM and RBM standards,tools, data provisioning, and reportingPartners with Research/Business Units and any external DM service providerto deliver high quality data management for all studies as assigned.Proactively drives quality and efficiency to meet timeline and milestones fordata management, ensuring scientific and operational excellence in supportof strategic imperatives and in collaboration with the cross functional studyteam (s).Ensure work carried out by DM providers is in accordance with applicable SOPsand working practices.Ensure the required study-specific DMandM documents in the Trial Master File(TMF) are of high quality and are filed contemporaneously.Ensure operational excellence in collaboration with partners for applicationof standards, data acquisition, proactive data review and data integritymonitoring, data cleaning, e-data processing, data access andvisualization, and database release.QUALIFICATIONSProficient experience using Oracle Inform EDC softwareExperience with Oracle DMW preferredWorking experience applying CDISC CDASH standardsDemonstrated successful experience in all relevant clinical data managementactivities in a BioPharmaceutical or CRO settingWorking knowledge of all phases of clinical trials and ability to assess anddetermine study requirement from protocol reviewStrong Project and Risk ManagementCRO and vendor oversight experience preferredStrong verbal and written communication skillsConsistent, detail oriented, communicative, dedicated to do a job well doneMinimum 5 years Data Management experience requiredWorking knowledge of clinical research, FDA and ICH, GCP, GCDMP, andrelated regulatory requirementsExperience using data visualization tools (e.g. Spotfire, jReview)Familiarity with MedDRA/WHO-DrugProficiency in the use of Microsoft Office Suite of tools (Outlook,Word, Excel, etc.)Bachelor's degree required or at least 15 years of relevant data managementexperience.This role can be remote based but we prefer new hires to be located at one ofthe listed locations and be on-site at least 3 days per week.The job location can be Collegeville PA, Peapack NJ, Groton CT, La JollaCA, or Cambridge MA#LI-PFESunshine ActPfizer reports payments and other transfers of value to health care providersas required by federal and state transparency laws and implementingregulations. These laws and regulations require Pfizer to provide governmentagencies with information such as a health care provider's name, addressand the type of payments or other value received, generally for publicdisclosure. Subject to further legal review and statutory or regulatoryclarification, which Pfizer intends to pursue, reimbursement of recruitingexpenses for licensed physicians may constitute a reportable transfer of valueunder the federal transparency law

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