Clinical Project Manager (US)

Project Management Manage the planning, execution, progress and completion of assigned clinical research projects

Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies

Maintain operational, financial and regulatory integrity and safety

Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third party vendors as required

Documents and Tools Manage a cross-functional team to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions

Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects

Project Team Performance Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/adverse event management, document management, statistical analysis and/or final report writing and publications

Ensure task completion performance meets or exceeds quality standards and sponsor/client, project and regulatory expectations and guidelines

Client/Sponsor Support Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations are appropriately managed by addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports