VIVEX Biologics

Clinical Operations

• 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.

Clinical Project Manager

Compliance

• Responsible for the coordination, compilation and submission of biologics and medical device applications.
• Develop and implement Chemical and Manufacturing Controls (CMC).
• Provide guidance to project teams on the regulatory framework from the FDA.
• Manage supplier and distributor qualifications and the company’s auditing program.
• Maintain voluntary accreditations, state licenses, and establishment registrations.

Clinical Project Manager

Director of Regulatory Affairs