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Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, PBRER). We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team.
$239,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Must meet all the requirements to receive required airport security badge and US Customs and Border Patrol clearance, including a successful completion of a background check and 10-year work history, Motor Vehicle Report and Drug screening.
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Experience and extensive working knowledge of MedDRA, WHO-DRUG, and proprietary safety databases Knowledge of FDA and EU regulations and ICH guidelines. Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
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A state-of-the-art (SOTA) fully-automated, high throughput wet laboratory in the premier Boston Seaport District for both data generation for AI model training as well as validation of the safety and efficacy of drug candidates that are outputted by our frontier AI models.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
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Responsible for leadership of Clinical Program and Trial Management, Clinical Supply Chain, Data Management and Study Start-up, and execution of all clinical programs supporting Clinical Development within the R&D organization.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The AD, Clinical Operations is responsible for managing all aspects of multiple clinical trials with emphasis on CRO, vendor and internal team management to drive a high functioning and results- driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
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Reporting into the Head of Research Strategy and Operations, an individual in this role integrates budget, contracting, purchasing, and resourcing data and information from across the business to create an overall holistic view of Research operational health.
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Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.
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Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry.
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Our goals are shared, our decisions data-driven and our camaraderie genuine. The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program, KT-621.
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This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III.
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Minimum of 5 years' experience as an operations and/or analytics contributor, with a proven track record of leading data-driven strategy design and implementation. Manage the commercial data warehouse requirements and master data management plan for timely, complete, and accurate reporting and analytics.
$194,856 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.
Full-timeExpandApply NowActive JobUpdated 5 days ago
data drug jobs Title: operations in Watertown, MA
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