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Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools. Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools.
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Act as a SME on core business software solutions (e.g., RAVE EDC system) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges. Lead the development of clinical study databases in the Rave EDC system according to the department SOPs, including programming complex Custom Functions in C.
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Experience with Rave EDC system and complex Custom Functions in C#. Experience with Rave EDC system and complex Custom Functions in C#. Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems.
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Oversee the documentation of clinical database structures, specifications, reports and other database-related tasks during the life of a clinical trial to ensure data quality and compliance with regulatory guidelines and company SOPs.
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Acclaimed for its sophisticated comfort food and voguish design, restaurant criticsand guestsall rave about Caf & Bar Lurcat. Acclaimed for its sophisticated comfort food and voguish design, restaurant criticsand guestsall rave about Caf & Bar Lurcat.
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Proficiency with CTMS, RAVE, Veeva Vault systems highly recommended. Proficiency with CTMS, RAVE, Veeva Vault systems highly recommended. The Manager, Global Clinical Operations (GCO) will be responsible for the direct functional management of a group Site Managers (SMs) in the Oncology Therapeutic Areas (TA) within GCO U.S. at Janssen.
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Job Field: Clinical Trial Project ManagementOrganization: Janssen Research & Development, LLC (6084) Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations.
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Plan and lead the design and implementation of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report form with cross functional teams.
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Activities include but not limited to, planning, design, programming, testing, validation, and all related documentation tasks. Extensive knowledge of processes and procedures in clinical data management.
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Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives. Extensive knowledge of clinical programming as it relates to business processes.
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Lead the development of specifications for complex systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users. Extensive knowledge of relational databases, systems, and programming languages.
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Ability to translate technical information to cross-functional teams. Title: Principal Clinical Programming Analyst. Schedule Notes: 100% Remote 6 month duration 20-30 Hours per week. Extensive knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databases.
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Extensive knowledge of their own area within the organization while contributing to the development of new concepts, techniques, and standards. Proven successful project management skills. Employment Type: Contractor.
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Duration: 06 Months-Contract on W2. Shift Timings: 8 AM to 5 PM. Location: Irvine, CA -92614.
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Duration: 06 Months-Contract on W2. Shift Timings: 8 AM to 5 PM. Location: Irvine, CA -92614.
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