Clinical Manager-TMI

Clinical Manager-TMI

About the job

• 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