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Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar.
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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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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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Assist with the review of monthly GP utilization files (GP rebate claims), 340B | PHS program, GTN accrual summary file, and GTN reporting package. Key Responsibilities Manage GP models, review, parallel calcs, and analyze reporting of programs requiring price reporting, per legislative requirements, including Average Manufacturers Price (AMP), PHS Price, Best Price (BP), VA/FSS (Federal Supply Schedule), Average Sales Price (ASP), non-Federal Average Manufacturer Price (nFAMP), Federal Ceiling Price (FCP), Industrial Funding Fee (IFF) and Unit Rebate Amounts (URA.
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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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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed) Subspecialty training in relevant therapeutic area preferred (Sickle Cell/Hemoglobinopathies) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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High school graduate or equivalent (Preferred) Fully vaccinated Experience in oral advocacy activities such as Speech and Debate, Mock Trial, Model United Nations, or similar (Required) Experience working at a summer camp: 1 year (Preferred) Competitive Public speaking: 2 years (Required) Compensation is set and will be discussed during interview.
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In-depth knowledge of claims, litigation, arbitration, and trial processes as well as excellent analytical, investigative, and negotiating skills. Managing costs, including use of coverage counsel and litigation costs as well as collaborating and working with the Litigation Management and Vendor Management teams ensuring cost management and the development and enhancement of the.
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The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. Develops trial designs that address study objectives that will support regulatory approval and market access.
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Oversee protocol development, amendments, and clinical trial data review, ensuring trials meet ethical and regulatory standards. Proven track record of successful clinical trial design and execution, particularly in early-stage oncology programs.
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Communicates a compelling vision of BMS clinical trials to outside organizations that generates respect and commitment to BMS as an industry leader in site and patient engagement efforts and functions as a subject matter expert on the drug development/clinical trial process.
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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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OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. The practice offers Hematology/Medical Oncology, Breast Surgery, Palliative Care, Radiation Oncology, and Clinical Trials & Research Programs.
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Take Risks:Embrace Risk, Practice “Trial and Error and Trial”. Job Summary: The Engineer I in Packaging will play a key role in the Drunk Elephant Package Engineering department to support new product launches and product line maintenance across assigned brand(s), from design brief to production execution and consumer complaints management.
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trial file jobs Title: trial in Monmouth Junction, NJ
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