18 days old

Senior Clinical Research Specialist

Medtronic
Brampton, ON L6V 3H3
Senior Clinical Research Specialist

Location:

Brampton, Ontario, Canada

Requisition #:

19000J0N

Post Date:

Oct 29, 2019


**Careers that change lives!**


**Bring your talents to a leader in medical technology andhealthcare solutions.** **Rootedin our long history of mission-driven innovation, our medicaltechnologies** **open doors.** **We support your growth with the training, mentorship, andguidance you need to own your future success.** **Join us for a career that changes lives.**


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 withKey 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.


**___________________________________________________________________________________**


**A day in the life!**


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.


Clinical Affairs


+ Leveragesclinical/scientific knowledge to provide strategic input for marketdevelopment initiatives, regulatory strategy, value-based healthcare and reimbursementprojects 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:


oResponsible for the Intake and facilitation of the
internal review of investigator-initiated research support requests


oFor 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 ofinterest to Canadian investigators and to the Canadian Medtronic office.

+ Consults with Study Managers prior to study start-up to provideexpertise on Canadian local laws/regulations and provide ongoing support forCanadian center start-up activities, enrollment and quality issues.

+ Works with local stakeholders to ensure the study fits intoCanadas strategy

+ Facilitate center start-up in collaboration with head office studyteam.

+ Assists study team in trouble shooting major Canadian site issuesand coordinate resolution with the study team.

+ Performs as needed site qualification and attend site initiationvisits

+ Liaises with Canadian regulatory for investigational testingauthorization submissions

+ Oversees clinical supply chain

+ Manages project budgetsas required


**Must Haves!**


+ Bachelor's degree in Science or nursing degree

+ A minimum 4 years experience supporting/coordinatingclinical trials or advanced degree with a minimum of 2 years relevantexperience


+ Exceptional problem-solving skills; ability tobalance analysis with decisiveness

+ Ability to build internal and externalnetworks

+ Strong presentation skills

+ Strong project management skills


Strong knowledge of clinical study
design


+ Excellent oral written communicationskills in English

+ High attention to detail and accuracy

+ Demonstrated ability to identify and adapt toshifting priorities and competing demands.

+ Knowledge of good clinical practices

+ Ability toTravel-20-30%

+ MS Excel, Word, PowerPoint, Outlook


**Nice tohave!**


PhD in Science highly preferred


Health economics


Knowledge of statistical analysis


+ MedTech or Pharma customer interactions

+ 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 Canadastrives through our vision to build a culture of inclusiveness through ourcommitment to employment equity and diversity. Discrimination is prohibited onany grounds protected under Canadian Human Rights legislation. Employmentapplications are encouraged from all members of our community. Upon request,candidates with disabilities will be accommodated during the recruitmentprocess._
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.

Categories

Posted: 2019-10-31 Expires: 2019-12-07

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Senior Clinical Research Specialist

Medtronic
Brampton, ON L6V 3H3

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