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Perform scheduled reconciliations of the Trial Master File (TMF) and ensure compliance with clinical study protocols. This position involves organizing, managing, and tracking key aspects of clinical studies, including Trial Master File (TMF) performance, scheduling, and reporting.
$62.5 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Years of mainframe experience in IBM JCL, CA, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities. years of mainframe experience in IBM JCL, CA, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities.
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Knowledge and experience of Master Data Governance (MDG), Hyperion FP&A and Blackline accounting applications and tools. Knowledge of Master Data Governance tool, Hyperion and Blackline.
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Master proficiency in data sharing processes, data access, and data taxonomy. Proficiency in Databricks, Apache Spark, and AWS services (e.g., S3, Redshift, Glue, EMR, Lambda). Preferred certifications: AWS Certified Solutions Architect, Databricks Certified Data Engineer, or similar certifications.
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BS degree plus minimum 6 years or Master degree plus minimum 4 years of experience OR PhD plus 1 year of experience in Pharmaceutics, Chemistry, Biomedical Engineering, Chemical Engineering, or related field with a strong background in nanoparticle-based formulation development & analytical characterization.
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Bachelor degree plus minimum 6 years or Master degree plus minimum 4 years of experience or PhD plus 1 year of experience in Pharmaceutics, Chemistry, Biomedical Engineering, Chemical Engineering, or related field with a strong background in nanoparticle-based formulation development & analytical characterization.
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Your role will involve applying state-of-the-art AI techniques to extract valuable insights from various image modalities such as OCT (optical coherence tomography), FAF (fundus auto-fluorescence), and CFP (color fundus photography) in diseases such as dry AMD and IRDs. Through the use of these innovative technologies, you will improve our understanding of structural biomarkers during disease progression, ultimately enhancing clinical trial efficacy and efficiency.
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Critical aspect of the role includes defining an agile quality and compliance strategy that supports Digital Data unit in their effort to establish a standardized, resilient, and sustainable data pipeline - including data sources, data quality, data governance, data management and master data management.
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The Candidate: Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience Master of Science in Analytical Chemistry/Pharmaceutics preferred or more years of applicable industry experience in support of pharmaceutical product development Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs.
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Strong Knowledge of Data Warehouses/Lakehouse architectures, Master Data Management, Data Quality Management, Data Integration, and Data Warehouse architecture. MBA / Master s Degree/Ph. D. is preferred.
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Resolves problems causing payer denial or failed Medicare edits as they involve the charge master. Educates HMH departments and physicians with respect to the use and maintenance of the charge master and charging philosophy.
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Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.) Pharming is seeking to hire a Clinical Trial Assistant (CTA) to bring general administrative support to the Clinical Operations Department and assistance to Project Manager(s), Clinical Project Coordinator(s) and Department Manager/Director(s) on the various tasks associated with conducting clinical trials.
$104,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our College of Nursing offers a Bachelor of Science in Nursing (BSN) degree program at 23 campuses and online post-licensure degree programs and certificates including RN to BSN, RN to MSN, a Master of Science in Nursing (MSN) with six Specialty Tracks, and a Doctor of Nursing Practice (DNP.
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trial master file jobs Title: trial master in Middlesex, NJ
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