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Continue to develop and maintain robust phase appropriate quality management systems to support clinical research, product development, manufacturing, and distribution activities (GMP, GCP, GLP, GVP.
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Ensuring research quality by practicing compliance and following the principles of Good Clinical Practice (GCP)/International Harmonization Conference (ICH), Health Insurance Portability and Accountability Act (HIPAA), Federal Drug Administration (FDA) policies and guidelines, and other applicable regulations (state and local.
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Understanding and working knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance required. 2-3 years' experience in a data/project management capacity, ideally within a clinical research setting.
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Extensive familiarity with clinical research. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images received.
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Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection.
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The Senior Local Trial Manager (Sr. LTM) is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
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The Senior Local Trial Manager (Sr. LTM) may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents. Solid understanding of the drug development process including GCP and local regulatory requirements.
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The Senior Local Trial Manager (Sr. LTM) actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles. Minimum 2 years of pharmaceutical and/or clinical trial experience is required (site monitoring experience is preferred), however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
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The Senior Local Trial Manager (Sr. LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Clinical Trial Project Management.
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Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list. Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed.
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Job Function Clinical Trial Project Management. Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements. Johnson & Johnson Innovative Medicine is recruiting for a Senior Local Trial Manager Immunology.
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Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams. Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.
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Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k.
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Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. The Senior Local Trial Manager (Sr. LTM) is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
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Based out of Detroit, MI area, The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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