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Support trial study start-up phases (support in writing study protocol, identification of investigators and KOLs, CRF review, Investigator brochure review, FDA/CA & IRB/EC assistance, support on medical and scientific questions/issues during trial follow-up phase.
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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.
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Familiarity with clinical data standards, including CDISC, SDTM, and ADaM , and experience with clinical trial data management systems (e.g., EDC, CTMS). Ensure that the platform enables data visualization and reporting that provides actionable insights into clinical trial performance (e.g., timelines, patient recruitment, data quality.
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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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Catalent Pharma Solutions in Somerset, NJ is hiring a Master Scheduler for the Supply Chain Department. Partner with Production Planner and Project Managers to understand client and project demand and translate requirements into long range master schedule.
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Bachelor's degree or equivalent experience background in publishing processes and automation, with an emphasis in IT Help desk using the following Google mail, XML, Word, Excel, Unix, databases, PostScript, and PDF file creation.
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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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Celsius Holdings, Inc. is a global consumer packaged goods company with a proprietary, clinically proven formula for its master brand CELSIUS®, based in Boca Raton, FL. A lifestyle energy drink born in fitness and a pioneer in the rapidly growing energy category.
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Form non-profit entities and prepare and file related applications for tax-exempt status. The firm is seeking a bright, energetic, and hard-working litigation associate. Handle all aspects of Trust Administration, including Fiduciary Accountings.
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TSO/ISPF, SDSF, File-AID, CICS, DB2). Extensive experience in mainframe software development, with hands-on expertise in languages like COBOL, PL/I, Assembler, or JCL.Proven track record of successfully leading and managing software development projects in the mainframe space.
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Bachelor or Master’ degree in chemical, biological or biochemical sciences Seeking 3 years of related experience in the biopharmaceutical industry. bioreactor, bioreactors, upstream, biochemical, clinical batches, bags, tube sets, columns, process manifolds, biosimilars, recombinant proteins M3.
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Certifications/Licenses Required Knowledge, Skills, and Abilities Equipment Utilized Physical Demands and Work Environment Overview The Master of Business & Science degree (MBS) is a degree combining the science curriculum from a traditional science master’s degree with a specialized set of business+ courses – including business, policy, and law.
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Job Summary: The Master Data Governance and Maintenance Manager is responsible for driving the business strategy by ensuring the creation, maintenance, and monitoring of high-quality, reliable master data.
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Develop and file, in tandem with the General Counsel and the Compliance Office, mandatory insurance regulatory filings related to ERM, including but not limited to the Enterprise Risk Report and the Own Risk and Solvency Assessment (ORSA) Summary Report.
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Fulfill the independent Reviewer responsibility of Design History File Documents to ensure they are organized, complete, thorough and compliant with regulatory and Amneal requirements completeness and be primary signatory on said documents.
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trial master file jobs Title: master in Raritan, NJ
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