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The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
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1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required; Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
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The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
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The CRA II will be responsible for the study start up process for AtriCure’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files.
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The Clinical Data Manager / Senior Clinical Data Manager (CDM) is responsible for data management activities across one or more studies from study start-up through study closure to ensure completion per established project team goals and objectives, including oversight of the CRO DM Vendor, if the project is outsourced.
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He/she will oversee the start-to-end processes for study start-up and ongoing study management. Work with ACC CRU Central to facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV's, and maintain communication with study teams and collaborative UPHS departments regarding progress.
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Collaborates with the Co-Directors of the Saint Luke’s Marion Bloch Neuroscience Institute, Manager of Research Coordination, and Neuroscience Research staff in determining prioritization and evaluating feasibility of proposed research studies, optimizing study start-up activities, and maintaining a balanced research portfolio.
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Works with the corporate office to evaluate recruitment plans and study start up. Responsible for contributing to the creation and execution of the clinical trial development strategy, study contract review, study budget review, negotiation, and in consultation with the finance department, the overall financial activities of the department.
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Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, regulatory documents, and other study-start-up requirements in partnership with the study PI and study team.
$66,700 - $103,400 a yearExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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OR A Ph. D. or equivalent doctoral degree in a related field of study such as: Sociology, Business Management, Business Administration, Public Administration, Social Science, Environmental Science, Geosciences, Political Science, Law Enforcement, or other fields related to the petroleum industry.
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PRINCIPAL DUTIES AND RESPONSIBILITIESStudy Start-up Responsibilities include: Draft/finalize Data Management Plan (DMP)Develop study-specific STATA code to format and manipulate imaging datasets according to the DMP and needs of each study.
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He/She will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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OR Three (3) full years of progressively higher level graduate education leading to a Ph. D. or equivalent doctoral degree in a related field of study such as: Sociology, Business Management, Business Administration, Public Administration, Social Science, Environmental Science, Geosciences, Political Science, Law Enforcement or other fields related to the petroleum industry.
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OR A master's or equivalent graduate degree in a related field of study such as: Sociology, Business Management, Business Administration, Public Administration, Social Science, Environmental Science, Geosciences.
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Material Handler & Machine Technicians are the perfect role to start with at Protolabs and work your way up. Use established procedures and work instructions to set up production equipment for operation.
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study start up jobs Company: Merck
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