Clinical Project Manager

Celerion is committed to swift, exceptional clinical research through translational medicine. They are seeking a Clinical Project Manager responsible for the independent management of multi-center site activities ensuring compliance to protocol and regulatory requirements.

Responsibilities:

• Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements
• Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline
• Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
• Coordinate activities with central laboratories and other external service providers/vendors
• Review and negotiate site budgets and contracts
• Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets
• Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion

Requirements:

• Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent
• Ability to work across multiple projects
• Excellent problem-solving and decision making skills
• Clinical research experience as a CRA or Research Coordinator is preferred
• Experience in support of business development processes; including budgets, proposals and bid defense planning and execution
• Experience with renal and hepatic impairment, infectious disease and tobacco studies is an asset
• Flexible and willing to travel up to 30% (regional)