Senior researcher / group leader
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The Senior Clinical Research Specialist will serve both internally and externally as the primary country clinical/scientific contact for the Canadian Minimally Invasive Therapies Group which includes metabolic surgery, surgical robotics and GI health. As part of the Clinical Affairs activities, this role will create and maintain scientific relationships with Key Opinion Leaders (KOLs) as well as manage external research support requests. They will strategically manage Canadian clinical evidence plans considering market needs, changing local environment and competitive evidence landscape. They will proactively seek out and drive solutions to meet market development needs. As part of the study facilitation activities, this role will work in collaboration with our global head office study teams as a liaison to organize the Canadian specific activities required for Medtronic sponsored study execution. This role works independently and under general direction only.
· Facilitates Canadian participation in Global 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 resolves local Canadian 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 Canadian clinical/investigational device supply chain.
· 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 maintains optimal relationships and effective collaborations with various internal and external parties.
· Drives local evidence dissemination & awareness.
- Leverages clinical/scientific knowledge to provide strategic input for market development initiatives, regulatory strategy, value-based healthcare and reimbursement projects as appropriate.
· Drives clinical evidence solutions to fill gaps for market development needs. This could include mining existing internal data, working with external partners or leading a Medtronic sponsored project.
· Evaluates Canadian clinical evidence needs/gaps and communication to global head office
· Executes clinical evidence dissemination activities that are of strategic relevance for Canada
· Actively builds and maintains optimal relationships with local partners and KOLs as well with the medical & scientific community
· External Research Program:
o Responsible for the Intake and facilitation of the internal review of investigator-initiated research support requests
o For approved ERPs, manage negotiation of the research agreement and subsequent financial or product support distribution
Liaison Role for Medtronic Managed Studies:
- Actively pursues head office internal study opportunities of interest to Canadian investigators and to the Canadian Medtronic office.
- Consults 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.
- Works with local stakeholders to ensure the study fits into Canada’s strategy
- Facilitate center start-up in collaboration with head office study team.
- Assists study team in trouble shooting major Canadian site issues and coordinate resolution with the study team.
- Performs as needed site qualification and attend site initiation visits
- Liaises with Canadian regulatory for investigational testing authorization submissions
- Oversees clinical supply chain
- A minimum of a Bachelor's degree in Science is required
- A minimum 4 years’ experience supporting/coordinating clinical trials or advanced degree with a minimum of 2 years relevant experience
- Ability to travel 20-30%
- Ability to build internal and external networks
- Strong presentation skills
- Excellent oral & written communication skills in English
- High attention to detail and accuracy
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Knowledge of good clinical practices
- Ability to Travel-20-30%
· knowledge of Health economics
- Bilingual - French an asset
PHYSICAL JOB REQUIREMENTS
· The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request, candidates with disabilities will be accommodated during the recruitment process.
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