Clinical Project Manager

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November 14

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VIVEX Biologics

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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.

201 - 500 employees

📋 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. • For assigned activities, understands project scope; manages site and study level activities. • 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. • Manages the finalization of clinical project documents according to the Protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports. • Collaborates with investigators and other clinical staff to ensure the quality of research. • Serves as a liaison between clinical, regulatory, marketing, customer care, quality, and commercial teams. • Interfaces with Key Opinion Leaders (KOLs), Principal Investigators, and site personnel to ensure high-quality data collection and strong site relationships. • Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines. • With the oversight of Clinical Affairs leadership, plans and oversees assigned clinical studies, from patient recruitment to data collection and lock. • Supervises the collection, storage and processing of data to maintain integrity and accuracy. • Oversees data integrity, query resolution, and interim analyses in partnership with Data management, Clinical Affairs colleagues, and Biostatistics vendors. • Identifies study risks and proactively implements mitigation strategies. • Ensures all sites and project-specific team members are trained and compliant with applicable requirements. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. • Supports development of documented departmental procedures, such as SOPs, Work Instructions, and associated forms and templates.

🎯 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 • Prior experience as a Clinical Project Lead or Clinical Manager • 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

🏖️ Benefits

• Able to travel up to 20%, domestically and internationally