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Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
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PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc. Experience in project managing the deployment of IT applications relevant to the Pharma Industry, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, Laboratory Information Management Systems (LIMS), and Pharmacovigilance (PV) systems.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Minimum of 1 year of experience in building case report forms (CRFs) using the Medidata Rave electronic data capture (EDC) system. Minimum of 1 year of experience in building case report forms (CRFs) using the Medidata Rave electronic data capture (EDC) system.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Experience with various clinical trial systems (EDC, CTMS, TMFs) trial master file organization, regulatory documents required. · Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, multiple clinical trial plans, EDC/CRFs, pharmacy manual, oversight manuals, clinical study reports, patient narratives, and Clinical Trial Agreements.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Facilitate UAT for database builds and or migrations to manage any impacts from mid-study updates to the EDC database and other data collection systems. Proficient in multiple EDC platforms, with strong understanding of database design and database concepts and related processes (database builds, updates, locks, etc.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Oversee vendors and actively participate in all UATs for vendor systems, including IRT, EDC, Central Labs, etc. Reporting to the Associate Director of Clinical Operations, this individual will have primary responsibility for trial management within in vivo, regenerative medicine, or oncology indications.
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Working knowledge of EDC systems – preferably Medidata RAVE. Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
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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.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Explosive Detection K9 Handler partners with a trained Explosive Detection Canine (EDC), or K9", to conduct searches in/at assigned client sites, including corporate buildings, loading docks, delivery vehicles, open areas and/or other situations as needed.
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Participate in data management initiatives such as evaluating technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards RequirementsBasic Qualifications:Bachelor's degree or equivalent in life science, computer science, or related discipline.
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Gathers content and integration requirements for EDC and ensures close collaboration / alignment with partners supporting other data collection systems (eCOA, Lab Transfers, IRT, etc. Experience managing non-EDC data sourced from laboratories, eCOA and IRT.
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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.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Masters degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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MSA Security, an Allied Universal® Company, is hiring a Explosive Detection Canine (K9) Handler. We offer medical, dental and vision coverage, life insurance, retirement plan, employee assistance programs, company discounts, perks and more for most full-time K9 handler jobs and other roles.
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edc job in Cambridge, MA
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