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Develop the Drug Safety & Pharmacovigilance budget and long-term forecast, creating timeline management systems and processes to ensure achievement of key deliverables Lead the process for acquisition and retention of safety vendors.
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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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The jobholder provides medical and drug safety expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation.
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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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Job DescriptionAs a key team leader in the Manufacturing Sciences & Technology function, the Associate Director, Analytical Sciences & Technology, Small Molecules- Drug Substance is accountable for all activities and resources associated with the commercialization and management of analytical activities for commercial programs for Vertex’s small molecules portfolio.
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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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The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
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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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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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The Site Lead is responsible for assisting with administrative duties such as, but not limited to; correspondence and memos; quality control; the recordkeeping and accuracy of training certifications, training scheduling; CPR first-aid scheduling; drug test and physical examination scheduling; payroll processing and time reporting, data entry and distribution of work schedules; other duties as requested by management.
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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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data management drug jobs in Waltham, MA
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