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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.
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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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Englewood Hospital, a community teaching hospital founded in 1890, consistently earns high marks for clinical excellence and patient safety. Areas of clinical excellence offered by the health system include cardiac surgery and cardiac care, cancer care, orthopedic surgery, primary care, spine surgery, vascular surgery, and women’s health, as well as bloodless medicine and surgery and minimally invasive robotic surgery.
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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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The Clinical Chaplain facilitates communication with caregivers outside the healthcare team; serves as a subject matter expert in pastoral care matters and collaborates with community clergy to provide ongoing spiritual support.
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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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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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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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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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Bachelor's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Minimum 1 year of clinical laboratory testing experience is required OR an MLS degree.
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QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
$183,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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clinical trial master jobs Title: trial master in Middlesex, NJ
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