Clinical Manager

Trudell Medical Group•London, ON

9d•Onsite

About The Position

At Trudell Medical International (TMI), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world. Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture. As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals. We’re actively searching for our next team member for the position of: Clinical Manager. Purpose: 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. Overall responsibility and input for activities including clinical studies, clinical regulatory documentation, KOL management, and marketing support.

Requirements

Degree in healthcare related scientific field (Pharmacy, Nursing, Respiratory Therapy, etc.), ideally with a relevant PhD or Masters
3 years of experience in clinical related roles, ideally within a pharmaceutical or medical device industry
Knowledge of Good Clinical Practices
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
Demonstrated ability to make good judgments

Nice To Haves

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
Experience in medical writing (abstracts, manuscripts, protocols) would be an asset
Experience with international markets, e.g., US, Europe, and Asia, is an asset

Responsibilities

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.