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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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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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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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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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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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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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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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Manages CDM Epic projects including documentation, file building, testing, validation, workflow decisions, and implementation. Resolves problems causing payer denial or failed Medicare edits as they involve the charge master.
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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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Assists in the definition of process parameters, procedural specifications, shelf life evaluations, coordinates pilot and manufacturing trials, documents trial results and coordinates product start-ups.
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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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Review Pilot/Trial Batch Cards submitted by Manufacturing Site. Write Bulk Holding Protocols and manage approval process as required. It’s the ripple effect that changes and improves everything for your family, your community, and the world.
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Clinical & Portfolio Solutions (C&PS) : We manage systems and processes supporting Patient & Investigator Portals, Clinical trial management, Electronic Data Capture, Trial Master File, Project & Portfolio Management and Shared Solutions.
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trial file jobs Title: trial master in Somerville, NJ
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