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Management, development, and execution of the financial IT systems and data within the CTO.Develops and implements financial policies and procedures for the CTO.Assesses financial data security and management practices in the CTO.Ensures compliance with government and University rules and regulations relating to financial aspects of Clinical Trials.
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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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At AbbVie, the Development Operations group conducts/manages clinical trials and provides therapeutically aligned, scientific strategy and operations management for the planning, execution and reporting of clinical development programs to enable successful global registration and commercialization of drug development projects.
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In close partnership with colleagues from Research teams from Client's Research and Development (PRD), you will play a key role in the deployment of novel digital and imaging measures into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers.
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Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.
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Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity.
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Work closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Data Management teams to align on trial objectives and ensure successful execution. Lead and oversee all clinical operations activities, ensuring alignment with company goals and objectives in neurology-focused clinical trials.
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Supervisory experience preferred; knowledge of clinical trials data management preferred; experience writing research grants and proposals strongly desired. Wellness: Lifestyle spending account, employee assistance program, health reimbursement account, and employee wellness program.
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This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III.
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Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution.
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Collaborate with cross-functional teams, including project management, data management, regulatory affairs, and quality assurance, to support clinical trial execution. Lead, manage, and oversee the day-to-day operations of clinical trials, ensuring adherence to GCP, regulatory requirements, and company SOPs.
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At least ten years of clinical research and/or clinical project management experience in global clinical trials (experience with early development oncology - i.e., Phase 1 oncology and/or hematology trials is preferred.
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The Director of Clinical Operations is responsible for the oversight of the Clinic, Regulatory Department, Clinical Research Coordinator Department, Data Entry Department, Nutrition Department, and Clinic Scheduling Department to support the execution of Phase I studies at Worldwide Clinical Trials Early Phase Services (Worldwide) in-house facilities.
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Oversees the management of staff, including Clinic, Regulatory Department, Clinical Research Coordinator Department, Data Entry Department, Nutrition Department and Clinic Scheduling Department and maintains department budgets.
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Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards.
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clinical trials data management jobs Title: operations
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