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 importation/distribution in collaboration with the Canadian Clinical Coordinator.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

KNOWLEDGE/EDUCATION
• Bachelors degree or
• Advanced degree
• Degree in Science, Nursing or Medicine
JOB EXPERIENCE
• Minimum 2 years of relevant experience with a bachelor’s degree or
• No relevant experience required with an advanced degree

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$80,000.00 - $120,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.