Project Manager - SERRM

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Job Title: YLM06H-Project Manager, SERRM (Safety, Epidemiology, Registries, and Risk Management)

Brief Description : Responsible for writing risk management documents, managing the operation of assigned risk management projects, interfacing with the client and collaborating with the scientific leaderships as well as internal UBC groups including Statistics, Business Development, Finance, Clinical Operations, and Patient and Physician Services

Specific job duties:

• Scientific Lead and manage the operations of risk management projects, epidemiologic studies and/or registries. Participate as needed in other epidemiology, registries and/or risk management-related projects Contribute to preparation, design and writing of Risk Evaluation Mitigation Strategies (REMS), Knowledge, Attitudes and Behaviour (KAB) protocols and surveys, reports, abstracts, and other risk management-related documents in collaboration with physicians and epidemiologists in the department Participate in internal and client project teams and meetings Observational Program Protocol development
• Lead and manage the operations of risk management projects, epidemiologic studies and/or registries. Participate as needed in other epidemiology, registries and/or risk management-related projects
• Contribute to preparation, design and writing of Risk Evaluation Mitigation Strategies (REMS), Knowledge, Attitudes and Behaviour (KAB) protocols and surveys, reports, abstracts, and other risk management-related documents in collaboration with physicians and epidemiologists in the department
• Participate in internal and client project teams and meetings
• Observational Program Protocol development
• Project Management and Finance Coordinate project-related activities, with direct responsibility for ongoing tracking, management of projects and timelines and follow-up of tasks and deliverables Coordinate project-related activities with the client and serve as point of contact Provide input to Contracts Management group to revise scope of work as needed for projects and budget revisions as required Where appropriate, communicate delivery or completion of project deliverables/milestones to Finance to track invoicing and follow-up Develop project timelines, schedule project meetings, and develop meeting minutes As necessary, working after business hours and on weekends may be required to ensure critical deadlines are achieved (e.g., FDA submissions)