Ipsen

Clinical Operations

Senior Clinical Project Manager responsible for execution and oversight of global clinical trials outsourced to CROs, ensuring timelines, quality, budgets, and study goals.
Collaborate with Clinical Development Program Directors, Medical Development Directors, and Ipsen team members.
Endorse CRO project plans, ensure GCP, local regulations, and SOP compliance.
Manage study budgets and tracking systems.
Lead cross-functional Clinical Study Team and external partners (CROs, service providers).
Identify process/technology improvements and participate in continuous improvement initiatives.
Oversee study team management and communication, set-up study team, contribute to protocol development.
Develop and control planning and study timelines, support RFPs and CRO selection.
Accountable for budget development, management, and tracking; ensure oversight of CROs and vendors.
Supervise country feasibility, site selection, and provide oversight for CTAs and Clinical Monitoring Leads.
Work with CROs and other teams on recruitment strategy and communications.
Ensure regulatory, safety and data requirements are met; participate in CRO meetings and escalate issues.
Travel as needed; ensure CAPA implementation post audits and assist with inspections.
Contribute to SOP updates, training, systems implementation and continuous improvement.
Comply with EHS regulations and contribute to environmental impact reduction.