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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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Join the Trial Court for an 8 to 10 week paid internship this summer and experience the tremendous work the Trial Courts do every day. At the Trial Court, we believe in Justice with Speed and Dignity.
$17 - $20 an hourFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Ensure that the Trial Master File (TMF) is maintained and up to date. Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations.
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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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You will focus on projects from the start of assay development to clinical trial implementation as well as data management to ensure we are obtaining high-quality data from our clinical trials.
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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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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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Mainframe Databases and File Systems: You need to know of these mainframe databases and file systems and have worked with at least one: DB2, IDMS, VSAM, IMS, Datacom, Adabas. Excellent written and verbal communication skills; including handling challenging Client or Associate Communications in high-pressure situations.
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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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In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, the Scotts Miracle-Gro company will not consider or approve payment regarding recruiter fees or referral compensations.
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They will edit various stages of video projects, and make revisions, based on review input from the project's Video Producer, as well as assist with the file management, backups, and archiving of assets.
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The Brain Modulation Lab is involved with several major NIH and industry-sponsored clinical trials and the Project Manager will support multiple active protocols, serve in the capacity of lead Clinical Research Coordinator of trial teams, maintain regulatory documentation, Standard Operating Procedures, and train staff members to ensure compliance.
ExpandApply NowActive JobUpdated 8 days ago
trial master file jobs Title: clinical research associate Company: Parexel in Waltham, MA
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