| Position Type: | Full-time |
| Location: | London, ON |
| Date Posted: | Apr 15, 2024 |
Job Description
Clinical Manager-TMI
About the job
As a member of our Medical & Scientific team, you will provide clinical and scientific support to maximize exposure within the health care community and to assist with local and international clinical strategies that support TMI’s new and existing products. As well as overall responsibility and input for activities including clinical studies, clinical regulatory documentation, KOL management, and marketing support.Responsibilities Include
CLINICAL TRIALS MANAGEMENT
- Support VP, Medical & Scientific Affairs by developing, recommending, and leading clinical development initiatives and research that generates evidence
- Ensure that key study targets are met by planning and tracking study timelines, deliverables, and budgets
- Ensure integrity of clinical trials by reviewing and assessing protocols
- Address TMI’s business needs by contributing to clinical presentations
- Support clinical research function by advancing other projects
- Support the development and execution of medical marketing strategies by assisting as requested
- Ensure compliance with applicable regulations or guidelines, i.e., as established by organizations such as PAAB, Health Canada, and FDA
- Ensure success of product development efforts by assisting with market research requirements
- Ensure that customer focused objectives are achieved by participating in product development initiatives
- Support the medical and science function in meeting publication objectives by assisting with abstract writing and coordination of publications
- Assist and lead the generation and maintenance of regulatory clinical documents such as; CEPs, CERs, PMSs, etc.
- Ensure that clinical related questions from sales business areas, distributors and consumers are adequately answered
- Demonstrate expertise (understanding and application) of key product performance requirements for TMI’s devices
- Maintain existing contacts and develop new ones so as to support the global KOL effort within the medical and science function
- Ensure internal and external parties have ready access to technical support, e.g., product development, customers, regulatory authorities, etc.
- Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
- Degree in healthcare related scientific field (Pharmacy, Nursing, Respiratory Therapy, etc.), ideally with a relevant PhD or Masters
- 5+ years of experience in clinical related roles, ideally within a pharmaceutical or medical device industry
- Experience in respiratory health and disease management an asset
- Recognized expertise in aerosol drug delivery gathered via clinical or industry experience is an asset
- Established network of key opinion leaders (KOLs) in the respiratory field preferred
- Knowledge of Good Clinical Practices
- Experience in medical writing (abstracts, manuscripts, protocols) would be an asset
- Good oral communication skills with ability to deliver presentations to professional audiences and sales teams
- Excellent written communication skills
- Good interpersonal skills with the ability to work independently and as part of a team
- Understanding of medical devices’ regulatory issues
- Demonstrated ability to establish and maintain effective interpersonal relationships
- Ability to operate with diplomacy and tact
- Experience with international markets, e.g., US, Europe, and Asia, is an asset
- Demonstrated ability to make good judgments
Hybrid
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