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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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Collect, review, and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the study. Collect, review, and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the study.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.
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Knowledge of cloud specific solutions related to gateways, streaming services, or file and database migration services. Experience writing IAC code using Terraform to deploy AWS resources. We are looking for a Full Stack AWS Engineer with extensive technical breadth of experience in JPasS and cloud technologies.
RemoteExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Generates all information obtained during the patient's pre-op stages and submits a completed pre-operative surgical package to the surgical facility as directed by that facility, thus ensuring that the patient file is complete, and patient is cleared for surgery.
Part-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Work with internal R&D teams and external patent counsel to prepare, file, and prosecute patent applications. Our team includes world-class molecular and synthetic biologists, protein engineers and gene therapy scientists working alongside software engineers, data scientists, and machine learning experts to transform the landscape of available gene therapy capsids.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Collecting, reviewing, and approving all required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and "audit ready" throughout the course of the study.
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As the Director, Clinical Documentation and Systems Operations, reporting to the Vice-President, Clinical Development Operations, you will lead and support Trial Master File (TMF) activities with the clinical study teams and be the study document subject matter expert (SME), advising and guiding clinical study teams on management of clinical trial study documents.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Nasuni is a leader in the SaaS Hybrid Cloud File Storage market, growing at 30% year-over-year with an 88% Net Promoter Score (NPS), 120% Net Revenue Retention (NRR), and 98.5% customer retention.
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KalVista also filed an MAA with the EMA in July 2024 and expects to file for approval in the UK, Japan, and other countries later in 2024. Produce, review and approve User Requirement Specification (URS) and User Acceptance Testing (UAT) documentation for IRT systems for randomization and allocation of IMP to clinical trials subjects.
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Manage site regulatory documents and Trial Master File (TMF). We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the BWH Center for Clinical Investigation (CCI), and collaboratively with PIs from Massachusetts General Hospital and University of Texas Southwestern.
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Knowledge of common file formats (JSON, XML, HTML, CSV, PO, YAML, STRINGS, RESX, PROPERTIES) including syntax and escaping. Assist with resolving customer pre- and post-processing challenges, including localization file prep.
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Ensure maintenance of the Trial Master File and lead periodic reviews to ensure inspection readiness. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies.
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File Name: Consulting – Tech Consulting - Cybersecurity & Privacy – Cyber Architecture - SAP Solutions - Manager. Expertise in core cybersecurity domains such as Identity Access Management (IAM), Data Protection, and Vulnerability Management, with a specific focus on integration within the SAP landscape.
$263,200 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Assist with the operations, maintenance, and record-keeping to ensure program compliance for the tax credit, HUD, and LIHTC-related requirements through regular file audits, property inspection, and timely reporting.
$70,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
file job in Milton, MA
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