Market Access
Governmental Affairs Manager in Denmark A leading healthcare organization in the Nordic region is looking...
Clinical Research
On behalf of a Danish biotech, we are seeking an experienced and self-driven freelance Clinical Project Manager (CPM) to manage the end-to-end project leadership of pivotal First-in-Human (FIH) studies. In this role, you will act as the sponsor’s primary project lead and be the central figure ensuring seamless execution from startup to completion. You will be responsible for driving the study forward, coordinating all internal and external activities, and ensuring that timelines, budgets, and quality standards are met. This is a flexible consultancy position around 15-20 hours/week with a duration of at least 4-5 months and the potential for extension. Key Responsibilities End-to-End Project Management: * Assume the role of sponsor project manager and drive all aspects of an FIH dose-escalation study. * Lead the project from the early synopsis stage through protocol development, plan creation, and preparation for regulatory submissions. Internal Coordination: * Act as the primary liaison between various internal functions, including CMC, Regulatory Affairs, Clinical Pharmacology, Data Management, and Biomarkers. * Ensure effective communication and alignment across the organization to drive the project forward. External Management and Communication: * Serve as the direct point of contact for the selected Phase 1 CRO clinic conducting the study. * Ensure a robust and proactive collaboration with all external vendors and subcontractors. * Represent the company professionally and constructively in all external dialogue. Operational Execution and Quality Assurance: * Oversee and manage all startup activities to ensure an efficient and timely study initiation....
R&D
Join Visibuilt to help develop the next generation of biobased materials for urban infrastructure. We...
Denmark