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Perform Trial Master File (TMF) reviews to ensure completeness and audit‐readiness. The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP.
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Experience with business applications like Oracle ERP, Salesforce, Coupa, Zuora, Workday, Adaptive Planning, Master Data Management processes. Reporting directly to the Director, Business Applications, this position will be responsible for leading data strategy, contributing to enterprise data lake & analytics platforms using Snowflake, Fivetran and DBT technologies and drive standardization, operational excellence across the organization.
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Job Overview: Seeking a Clinical Research Scientist with strong expertise in Oncology, Immunology, or Immuno-oncology to lead the implementation, planning, and execution of clinical trial activities, collaborating with various stakeholders and driving Clinical Development strategy in a fast-paced, collaborative environment.
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Azure File Share, Roles/Access management and Services Monitoring and reportingSecurity Sentinel maintenance and management, Firewall managementSetup & manage Queues & print servers in AzureAzure-VDI installations or applications installed on Windows VDI.
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The Senior Scientist plays an integral role in the development and hands-on execution of critical projects that support the Heme Translational Medicine Department's aims in translational science, clinical trial support, and pre-clinical drug development.
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Leveraging Mass General Brigham OnCore Clinical Trial Management Systems, MGB PeopleSoft, and other applications supporting research, the CTCBO is responsible for providing consistent and centralized administrative support managing financial reimbursement for industry-sponsored clinical trials.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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The Mr. Appliance Academy is designed to take you from Apprentice to Master Technician quickly. You aren’t afraid to research new equipment and take advantage of training opportunities to expand your knowledge and skills.
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This candidate must be an experienced BI developer who is also able to manage requirements gathering and client interactions along with being proficient in common BI tools like QlikView, Qlik Sense, Tableau and Power BI. The candidate will be expected to work closely with Master Data Management, Data Warehouse, and Sales Operations teams to ensure overall project success.
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Knowledge of Master Data Management platforms, particularly Informatica MDM or Azure Purview. Stay up-to-date on the latest Master Data Management and Data Governance services and technologies.
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Research Associate/Senior Research Associate. Regularly communicate results within the research organization and at conferences. Minimum 1-5 years with MS, 2-5 years with BS of work experience in a research setting.
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The Separation Sciences group in Discovery Chemistry at our client in Boston, MA is seeking a candidate to join their team whose mission is to analyze and purify novel medicines prepared by their medicinal chemist colleagues.
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We seek an organized, highly motivated, full-time Clinical Research Coordinator I (CRC) to join our Dystonia Partners Research Bank team in the Department of Neurology at Massachusetts General Hospital.
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Strong Programming skills with good understanding of concepts such as OOPS, design patterns, master data management & Ontology development. Master Data Management / Data Quality Management / Governance.
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trial master file jobs Title: clinical research associate Company: Parexel in Lexington, MA
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