Brian Fortin Email Address

Senior Clinical Project Manager

FM Global's multinational presence and capabilities allow us to provide seamless insurance solutions, services and claims response around the world.

Lead author for protocols and informed consent forms, lead on developing of case report forms, develops Monitoring Plan for a project, participate in development of statistical analysis plan & safety plan, primary contact for cross-functional study team. Communicates and effectively problem-solves issues through team interaction and communicate effectively with senior management on study status. Conduct Key Opinion Leader meetings with industry experts for clinical initiatives Creates, maintain and is accountable for study budgets and timelines. Assists in leading activities of Clinical Research Associates (CRAs) assigned to project, including role of primary contact for contract CRAs, and for study vendors, including CRO, clinical supply and central labs. Reviews case report form completion guidelines, logic checks and data handling guidelines. Initiates and assist in the production of all clinical reports for company and regulatory requirements. Prepares internal files and investigational sites for clinical quality and FDA audits/inspections. Responsible for compliance and completeness of Trial Master File (TMF), initiates investigational product planning with cross functional team, develops and negotiates site budgets, proactively identifies issues and develops problem-solving strategies for assuring study timeliness are met, contribute to ongoing departmental training processes, performs monitoring and co-monitoring visits, attend operation room procedures to support study protocols .