Associate Clinical Project Manager

Benefits

Qualifications

• •Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO
• •Knowledge of international regulations and guidelines (ISO
• •14155/GCP) and clinical study design and implementation
• •Working knowledge of medical terminology
• •Capability and willingness to learn device function
• •Ability to interface effectively with medical professionals
• •Strong analytical and organization skills, with excellent attention to detail and accuracy
• •Project oversight and tracking capability
• •Good oral and written communication skills
• •Ability to work autonomously with excellent organizational skills and ability to…
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Responsibilities

• •Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics
• •Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools
• •Oversee and provide clinical input for the design of the Case Report Forms and electronic databases
• •Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products
• •Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation
• •Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required
• •Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports
• •Assure clinical studies are adequately managed to meet the protocol objectives and schedules
• •If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies
• •Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified
• •Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds
• •Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable
• •Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines
• •Effectively communicate with Liva Nova study management, participating sites, and any vendors on issues, questions and/or study updates
• •Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times
• •Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC)
• •For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery
• •Maintain device accountability plan and report
• •Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries
• •Coordinates closeout of sites/study, archive study documents
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