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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
- 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)
- Business Development
- Support development of proposals – both description of services and budget
- Attend client meetings as needed including bid defense meetings as well as relevant industry meetings
- Present at industry meetings when appropriate
Supervisory Responsibility:N/A
Desired Skills and Qualifications:
- Bachelor’s degree in life sciences, healthcare, and/or public health or equivalent
- Experience in protocol writing, study design and operations is helpful, as is familiarity with clinical trials, drug development and medical and scientific terminology
- Strong written and verbal communication/ interpersonal skills
- Ability to work independently, yet function well in a small team environment
- Ability to prioritize and work on multiple projects simultaneously
- Knowledge of project management techniques and tools
- Professional, organized, detailed-oriented with a high degree of accuracy, self-motivated and quality driven
- Enjoys fast-paced environment, challenge of learning about different health-related and research areas
- Strong computer skills (