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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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Understand clinical business systems and capabilities for your respective GDO function, including but not limited to: flexible site engagement, external data acquisition, global data management, and electronic data capture (EDC), clinical trial management systems (CTMS), and Trial Master File (eTMF), SPOT lite.
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RequirementsA PhD in oncology/immuno-oncology, or related field, with at least eight or more years of translational research, applicable biomarker, and/or clinical trial experience. A strong publication record demonstrating relevant experience in drug development, translational research, biomarkers and/or clinical trials.
$142,500 - $237,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Prior experience in Analytics, Big Data, Cloud, Digital Asset Management, Master Data Management and Data Warehousing as it related to Health Plans; Provide solution designs in the area of Analytics, Big Data, Cloud, Digital Asset Management, Master Data Management and Data Warehousing.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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In addition, a forensic psychologist with training and experience in clinical neuropsychology would be considered. The practice is a unique specialty practice that also serves as an approved training site for postdoctoral fellows in neuropsychology through ACPN and doctoral level externs, and also incorporates a clinical practice focusing on neuropsychological and psychological treatment of TBI, PTSD, ADHD and other trauma-based, neurodevelopmental and other neurocognitive disorders.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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These digital solutions span across the BMS value chain from clinical trials to manufacturing, to commercialization and market access. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements. Experience with downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.
$157,100 - $217,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Career Paths: Fast-track your journey to becoming a Board Certified Behavior Analyst (BCBA) or Clinical Leader. Career Paths: Fast-track your journey to becoming a Board Certified Behavior Analyst (BCBA) or Clinical Leader.
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Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts , and medical terminology used in the analysis and submission of clinical data.
$102,000 - $129,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Microsoft Suite+ Clinical Trial Management System (CTMS)+ Electronic Trial Master File System (eTMF)+ Document Exchange PortalsIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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clinical trials trial master file jobs Title: trial master file in Skillman, NJ
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