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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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As an Information Architect, you will deliver innovative data management, integration, and streaming platforms to underpin cutting-edge drug discovery processes. Use your technical skills to extend and enrich data management platforms to support new modalities, e.g., Gene Therapy, Proteomics, Functional Genomics and more.
$135,440 - $177,765 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents. Responsible for performing data management oversight activities in support of Leap Clinical Studies by overseeing the activities of the CRO DMs, from study start-up through to study closeout, to ensure adherence to scope of work and service agreements, and that the deliverables are on time, within budget and are of a high quality.
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This individual will have the opportunity to join a dynamic interdisciplinary team and also be part of the Flagship ecosystem of companies, providing unique networking benefits through regular meetups, collaboration, and an environment of development and discussion around new ideas shaping the fields of computational biology, ML/AI and data-driven drug discovery.
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Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations. Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards.
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Collaborate with Data Management, Drug Safety, and Digital to support new technologies and innovative solutions in improving the effectiveness, automation, and quality of safety data integration and processing.
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Derive recommendations and propose solutions for tailor-made and integrative drug disposition questions in the Bx arena (Bx Portfolio risk management) Propose and review ADME/BA solutions and action plans to guide the drug development process.
$183,200 - $274,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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At 1910 Genetics, we put computation at the heart of drugdiscovery, blending expertise in computational chemistry, structuralbiology, pharmacology, genetics, data science, and softwareengineering to develop drugs for previously undruggable targets.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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Monitoring responsibilities Provide expertise and oversight for monitoring related activities and for monitoring staff which may include: Reviewing protocols and creating data monitoring proposalsReviewing monitoring status, query resolution and reports Ensuring DMC-wide compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) 5.
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Working with AVEO management and the CMO to generate technical protocols, reports and batch records to support the cGMP manufacture of drug substance. The Sr Manager/Associate Director of Technical Operations oversees new process implementation and scale-up, manages data review, CMO relationships, and technical aspects of substance development.
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Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
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Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans. Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans.
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The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs. Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization.
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Proficiency in statistical programming languages (e.g., SAS, R) and clinical data management systems (e.g., Medidata Rave, Oracle Clinical) is essential. The Senior Vice President (SVP), Head of Data Analytics leads a multidisciplinary team responsible for biostatistics, statistical programming, and data management.
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data management drug jobs in Cambridge, MA
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