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Manage day to day LIMS activities for method qualification/validation and clinical study support including user training, troubleshooting, study setup, and management of clinical sample reconciliation and data transfers in line with regulatory data standards.
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Perform field and greenhouse routines, such as installing and maintaining various sensors, sensor data collection, field/greenhouse measurements, plant/soil/water/greenhouse gas sample collection and processing for laboratory analyses.
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Oversee and/or execute on assigned strategic, operational and/or tactical deliverables (e.g., EDC development, TMF QC, sample management at labs, etc.) Support data management (DM) activities such as reviewing study-related support materials created by DM, including the study manual, edit check manual, clean patient data tracker, listing review process and the SAP; participate in DM related activities (as needed) and data review / cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
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Provide hands-on leadership for the QC Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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This includes partnering with PMed Biomarker Leads and being responsible for editing clinical documents, sample management, data management, cross-functional teams, budget management and strategy documents.
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The Necropsy Technician I will also be involved in assisting with sample management. Necropsy study set up including but not limited to data sheet creation, cassette, and tube labeling.
$18 - $23 an hourFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Key responsibilities of the position include establishing the technical setup of biobank infrastructure, development of Standard Operating Procedures (SOPs), oversight of sample management and data, and management and training of personnel.
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Fulfillment of data quality objectives (DQOs) for all field collected data and samples; responsible for data quality during pre-field preparations, field work execution, sample management, and documentation.
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Has an opening for an experienced Geologist or Hydrogeologist in our Sacramento or Oakland office to assist with a variety of projects including data management, site investigations and remediation.
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Oversee data and sample management, including compliance checks and helping teams prepare for audits. Project Manager work includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, and development of key study documents include protocol, consent, and CRFs. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics.
$51,824 - $81,441 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Participate in the deployment and configuration of software systems for stability and sample management (e.g., LIMS.
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Reviews sample run data and quality control data and ensures all regulatory compliance standards are met while following established SOPs. Ensures proper entry of specimen data and testing results into databases or the laboratory information management system (LIMS), providing oversight of junior staff activities.
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The Scientist may represent the stability function on Technical Product Teams and also assist with stability study generation, sample management, stability data. Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
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Provide support to data management staff - e.g., storing of data, data entry, data cleaning and data integrity checks. They will administer the research protocol, which involves completing a neuroimaging protocol, administering questionnaires via Qualtrics, collecting physiological data while participants complete a speech task, providing instructions for the collection of salivary assays performed at home, ensuring all documentation are completed that data is saved, backed-up, and preprocessed in a timely manner, as well as assist with other duties in the lab as needed.
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