Clinical Project Manager

🔥 15 hours ago

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VIVEX Biologics

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201 - 500 employees

VIVEX develops and delivers innovative allografts designed to support the body’s healing potential to help improve patient outcomes and quality of life. Our medical technologies date back 50 years to the founding of The University of Miami Tissue Bank in 1970. Since that time, we have experienced multiple firsts in clinical and scientific achievements. VIVEX’s strategic plan is focused on the development of new innovative allografts, research and development, enhancement of manufacturing capabilities, and sales and marketing efforts.

📋 Description

• Contributes to the development of clinical strategies aligned with regulatory and commercial goals. • Collaborates with R&D, Regulatory, and Marketing on clinical trial designs and endpoints. • Prepares and presents findings of assigned studies to internal and external stakeholders. • Leads and manages the execution of assigned clinical studies. • Oversees protocol development, site selection, budgeting, contracting, and CRO/vendor management for assigned studies. • Ensures adherence to timelines, budgets, and enrollment targets. • Manages resources and quality of clinical projects. • Ensures all clinical activities for assigned studies are compliant with FDA, ISO, and ICH-GCP regulations. • Prepares and reviews study documents including protocols, informed consent forms, monitoring plans, and clinical study reports. • Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines. • Identifies study risks and proactively implements mitigation strategies. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related field • 5–8 years of experience in clinical research, with at least 3 years in a management or lead role • Strong knowledge of FDA regulations, ISO 14155, and ICH-GCP • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) • Experience working with CROs and clinical trial vendors • Full working proficiency in English.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development