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We are in search of an adept cloud software engineer with a proven track record as a technical lead (product owner) for Pison Cloud on Google Cloud Platform (GCP). Over 5 years of experience developing microservices to GCP, AWS, or similar cloud environments.
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This Cloud Infrastructure Engineer should have practical experience in administration of Microsoft Azure and other cloud technologies such as GCP. A strong familiarity with compute, network, and storage in Azure, as well as Azure Active Directory, part of Microsoft Entra.
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Ensures a robust framework for the quality oversight, review and approval of Quality Management System (QMS) standards and procedures for regulated activities in Clinical Research (GCP), Pharmacovigilance (GVP) and Medical.
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Extensive experience in at least one cloud platform (e.g. AWS, GCP, Azure) and associated machine learning services, e.g. Amazon SageMaker, Azure ML, Databricks. Experience working in accordance with DevSecOps principles, and familiarity with industry deployment best practices using CI/CD tools and infrastructure as code (e.g., Docker, Kubernetes, Terraform.
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Proven experience building enterprise-grade software in a cloud-native environment (GCP or AWS) using cloud services such as GCS/S3, Dataflow/Glue, Data proc/EMR, Cloud Function/Lambda, Big Query/Athena, Big Table/Dynamo.
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Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.
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Familiarity with Databases and Data Platform technologies such as GCP BigQuery and MongoDBFamiliarity with configuration management tools (Ansible, Chef, Puppet). Cloud Provider Expertise:Utilize deep expertise in at least one major cloud provider (AWS or GCP) to design and optimize cloud-based solutions.
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Expertise in developing and deploying machine learning models in cloud environments (AWS, Azure, GCP) w ith a deep understanding of cloud services, architecture, and scalable solutions. Strong knowledge, experience, and fluency in a wide variety of tools including Python with data science and machine learning libraries (e.g., scikit-learn, TensorFlow, PyTorch), Spark, SQL; familiarity with Alteryx and Tableau preferred.
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Role OverviewThe Human Research Compliance Specialist (compliance auditor) provides education and support to researchers and is responsible for performing audits of IRB-approved clinical research protocols across our institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice (GCP) guidelines, as well as with our organization's clinical research policies.
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LabsQA Team are responsible for the strategic development and delivery of a GLP/ lab GCP, HBS and GLS risk-based audit program. Significant Audit experience in pharmaceuticals or a related industry, i.e., laboratories involved in GLP, Lab GCP, HBS and CLIA.
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Certifications for any of the cloud services like AWS, Snowflake, GCP or Azure. Understanding of enterprise data management concepts (Data Governance, Data Engineering, Data Science, Data Lake, Data Warehouse, Data Sharing, Data Applications.
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We are looking for a professional with expertise in laboratory quality management systems (GCP, GLP), clinical Bioanalytics (mainly large molecules), pharmacokinetics, standard laboratory requirements, and familiarity with quality & information management systems.
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Relevant hands on experience in the engineering and administration of Microsoft Azure and other cloud technologies such as GCP. Work closely with the Information Security, Engineering and Operations and other cross functional teams in the assessment, design and implementation of robust cloud security solutions across major cloud providers such as Azure and GCP.
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Knowledge of GCP, FDA, ICH, CDISC, CDASH regulations and guidelines. Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred. Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform.
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Stay abreast of industry and regulatory standards and GCP requirements related to TMF and provide strategic guidance. Extensive knowledge of Study, Country, and Site level essential clinical trial documents and knowledge and understanding of the clinical trial process and GCP/ICH guidelines.
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