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Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$239,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Veeva's Vault RIM suite is the industry's only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing, and archival on a single cloud-based platform.
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Apply computational tools to analyze complex data, particularly in the context of drug discovery or biological sciences. Minimum of one (1) year of experience with strong domain knowledge in data science and informatics with a focus on experimental data interpretation and specimen management.
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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
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Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trials, Data Entry, Drug Discovery, Due Diligence, Electronic Components, Gene Therapy, Lifesciences, Medical Research, Microsoft Office, Modeling And Simulation, Patient Care, Physics, Translational Medicine, Waterfall Project Management.
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Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management.
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Lead Drug Safety operations, data analysis, risk management, and safety communications. Job Overview: The Drug Safety Physician oversees pharmacovigilance activities, ensuring the medical review, data management, and regulatory compliance of safety events to maintain drug safety and efficacy.
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Key member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, regulatory and quality. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets.
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Key Responsibilities: Study Execution in a GCO compliant way Be accountable for study recruitment Ensuring highest quality of data generation and collection Ensuring study activities are GCP compliant Medical monitoring CRO Management Collaborate with Biostatistics / Data Management for statistical support and data capturing.
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These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines.
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Oversee CRO and vendors, and participate in study start-up activities, including development, review, and approval of eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation specifications and User Acceptance Testing.
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Support the oversight and management of global business partner and vendor safety data exchange agreements (SDEAs), pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange requirements.
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A number of years of experience in proteomics, genomics, transcriptomics, images or clinical data analysis for biomedical research. Deep understanding of how deep learning / representation learning can be used to accelerate biomedical research on protein, omics, histological or clinical data.
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Proficiency in statistical software (e.g., SAS, R) and clinical trial data management systems. Ensure high-quality, timely analysis and interpretation of data to inform critical decisions in drug development.
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Assists and supports the pharmacy manager in analyzing performance data including pharmacy financial, customer service, and implementation of procedures for pharmacy asset protection and inventory management.
$41.15 an hourFull-timeExpandApply NowActive JobUpdated Today
data management drug jobs in Woburn, MA
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