At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Clinical Research Specialist will serve both internally and externally as the primary country scientific contact for the business sector. As part of the Medical Science activities, this role will create and maintain scientific relationships with KOLs and drive evidence informed decision making. They will strategically manage local evidence plans considering market needs, changing local environment and competitive evidence landscape. As part of the clinical study liaison activities, this role will work in collaboration with our global head office study teams to organize the Canadian specific activities required for Medtronic sponsored study execution.

A Day in the life:

• Oversees, designs, plans and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site and vendor selection.
• People working within region/country may also have the responsibilities that include:
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.
• Responsible for reporting complaints and Adverse Drug Reactions (ADR)
• Medical Science Liaison Activities
• Identifies, plans and executes strategic evidence dissemination in alignment with sector priorities including the creation of literature summary tools and presentations to internal and external audiences. 
• External Research Program:
• Responsible for the Intake and facilitation of the internal review of investigator-initiated research support requests, for approved ERPs, manage negotiation of the research agreement and subsequent financial or product support distribution
• Actively builds and maintains optimal relationships with Key Opinion Leaders and societies within the medical & scientific community.
  • Evaluation of Canadian clinical evidence needs/gaps and communication to global head office
  • Leverages KOL relationships and clinical/scientific knowledge to provide strategic input for market development initiatives, regulatory strategy and reimbursement projects as appropriate. 
• Provides scientific support for congresses including identifying key scientific sessions, coordinating MDT abstract submissions, and arranging KOL research discussions. 
• Provides scientific support for Advisory Board planning and execution
• Evaluates major local evidence gaps and consider strategies to fill
• Responsible for responding to unsolicited requests for information on unapproved products and off-label uses in collaboration with head office Medical Affairs team. 
• Liaison Role for Global MDT Sponsored Studies:
• Consult with Study Managers prior to study start-up to provide expertise on Canadian local laws/regulations and provide ongoing support for Canadian center start-up activities, enrollment and quality issues.
• Work with local Marketing and Regulatory to ensure the study fits into Canada’s regulatory strategy.
• Work with Field staff, Marketing and Regional Managers to choose optimal study centers with minimal overlap between studies. 
  Oversee center start-up activities in collaboration with head office study team. 
• Assist study team in trouble shooting major clinical study issues and coordinate resolution with the study team. 
• Actively pursue head office internal study opportunities of interest to Canadian investigators and to the Canadian Medtronic office. 
• Perform as needed site qualification visits 
• Liase with Canadian regulatory to submit centers to Health Canada for investigational testing authorization. 
• Oversee clinical product