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S upport the GCP Vendor Audit Schedule including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization liaising with QA Vendor Auditing. 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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Works with each person-served on NAVIGATE Individual Resiliency Training (IRT) and other EP CSC required EBPs. Primary responsibilities will include individual therapy, NAVIGATE Individual Resiliency Training (IRT), psychoeducation, skill building, and coaching to persons receiving Discovery Team Services.
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Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT and EDC platforms. Establish governance and oversight of all clinical supply vendors including, but not limited to, IRT/RTSM, labelling, distribution, storage, transfer and destruction.
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Demonstrated knowledge of IRT operations, from theory to practice and from end-to-end process view to tactical system activitiesDemonstrated experience in IRT system definition and IRT vendor managementExperience working in Quality systems for issue and documentation management.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Lead review of supplier SOWs and accuracy of clinical outsourcing vendor agreements including CRO, IRT, Central lab, eCOA, ECG and electronic data capture as well as manage vendors with respect to contracted.
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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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Participates in UATs, e.g., EDC, IRT. Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF.
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Participates as a member of Integrated Resource Team (IRT) at the direction of MRC VRC. Delivers CIES service components, as identified on the Individualized Plan for Employment targeted at job development and placement, vocational support, skills building, etc.
$43,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience managing IRT teams (direct line management) Associate Director, Clinical Trial Supply Management, IRT Systems. Relevant professional experience (usually +7 years) with IRT systems in Clinical Trial in Pharmaceutical or Biotech or any other equivalent industry setting.
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Complete the IRT training and consistently engage in the fidelity and certification supervision that takes place biweekly. Provide assessment, IRT intervention and complete MAPNET assessment batteries for data outcomes and meet measurement and treatment tracking requirements.
$35 an hourPart-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Development of the IRT supply strategy (resupply parameters, DNS, DND). They will be required to work with several stakeholders: Quality Control, IRT Specialists, Global Supply Chain, Clinical Operations and logistics department in different countries.
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PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc. The project list is changing based on the roadmap and the discussions they are having but it includes but is not limited to, External Collaborative Authoring tool for R&D, External Collaborative Authoring tool for Ops, IRT system implementation (TBD), CMDB, PV Safety Database, PV Safety Doc repository.
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Strong familiarity with source systems (e.g., Medidata/EDC, IRT) and how data is sourced and stored. Proficient in clinical data (EDC (Electronic Data Capture), IRT (Interactive Response Technology), and other relevant sources.
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Hands-on support of clinical systems and other KalVista applications such as data capture (EDC/ePro), randomisation and drug supply (IRT), eTMF and analytics & reporting. Hands-on support of clinical systems and other KalVista applications such as data capture (EDC/ePro), randomisation and drug supply (IRT), eTMF and analytics & reporting.
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Participates in UAT for EDC/IRT. Participates in UAT for EDC/IRT. Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management. Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines.
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irt job in Lexington, MA
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