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Clinical Research Specialist

Medtronic


Location:
Dublin, CA 94568
Date:
03-12-2020
2020-12-032021-02-08
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Job Details

Clinical Research Specialist

Location:

Dublin Lake Drive, County Dublin, Ireland

Requisition #:

20000EI1

Post Date:

Dec 01, 2020


**Careers that Change Lives**


We're a mission-driven leader in medical technology and solutions with a
legacy of integrity and innovation. Be a part of a community of experts
committed to ensuring quality, affordable healthcare worldwide. Come strengthen
your specialized skills and enhance your expertise. We'll support you with the
training, mentorship, guidance, and networks you need to advance, and empower
you to work in the way that's best for you.


And we are currently
looking for a **_Clinical Research Specialist_** to join our MITG team in
Dublin.


**A Day in the Life**


Within EMEA the MITG Clinical Affairs Department plays a
strategic role in deciding an effective clinical program for all MITG
therapeutic areas. The objective is to produce credible medical-scientific
evidence to enable informed decisions on the management of identified disease
states.


The
MITG Clinical Research Specialist:


+ coordinate the Regional External Research Program (ERP)Review committee meeting for assigned business

+ manage External Research Program (ERP) in EMEA frominitial submission to study close-out/publication

+ adhere as appropriate to GCP, ISO14155 guidelines andMedtronic Standard Operating Procedures in order to meet the needs of allMedtronic Business Units

+ collaborate with global and regional medical affairscolleagues, on the strategic pathway of specific therapeutic area/diseasestates

+ contributes to the Regional ERP Review committee meeting

+ manages assigned ERP programs across differenttherapeutic areas

+ ensures the successful and timely execution of clinicalmilestones

+ complies with applicable quality and regulatory standards

+ ensures achievement of MITG Clinical Affairs departmentalobjectives on time and on budget

+ coordinates all aspects of the assigned Regional ERPReview committee meeting and collaborates with the Global ERP review committee

+ manages allocated MITG ERPs throughout their entire life-cycle from initial submission, approval process, contract negotiation, activeStudy, budget management, device return and publication

+ responsible for budget, payments and invoicing ofassigned ERPs

+ drives contract negotiation and finalization

+ logistically manages the coding, shipment and return ofdevices

+ maintains Trial Master Files in Vision Tracker of allassigned ERPs

+ ensures compliance with applicable quality and regulatorystandards

+ responsible for reporting and presenting on assigned ERPsto all stakeholders as appropriate

+ assists in development of internal clinical affairsoperating procedures and policies in relation to ERP process

+ responsible for KOL management in relation to ERPs

+ review assigned marketing material for clinical accuracyand scientific rigor

+ Perform other duties to support Clinical Affairsactivities as required.


In return, we will provide you with great training and
development opportunities in a growing business where innovative solutions are
delivered by industry experts.


**Must Haves**


+ Bachelors degree in biological sciences or a related medical/scientificfield

+ 3+ years of relevant experience in clinical research,preferably in the medical device industry

+ Proficient knowledge of medical terminology

+ Expertise with ISO14155, GCP and regulatorycompliance guidelines for clinical trials

+ Ability to work in a diverse team environment and withglobal and International teams and to adapt to changing priorities

+ Ability to identify problems, develop and implementsolutions to address study issues.

+ Ability to work with a minimum of supervision.

+ High attention to detail and accuracy

+ Advanced written and oral communication skills

+ Able to manage multiple tasks independently

+ Willingness and ability to travel overseas 20 to 40% ofthe time

+ Advanced written and spoken English.


**Your Answer**


Is this the position you were waiting
for? Then please apply directly via the apply button!


**About Medtronic**


Together, we can change healthcare
worldwide. At Medtronic, we push the limits of what technology, therapies and
services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday.
It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create
meaningful innovations - but we will only succeed with the right people on our
team.


Lets work together to address universal healthcare needs
and improve patients lives. Help us shape thefuture.


Whatever your specialty or ambitions, you
can make a difference at Medtronic - both in the lives of others and your
career. Join us in our commitment to take healthcare Further, Together.


At Medtronic, you will find a diverse team of innovators who
bring their unique backgrounds and their individual life experiences to work
every day. We work hard to cultivate a workforce that reflects our patients and
partners, we believe it is the only way to drive healthcare forward. We want to
attract a diverse workforce, regardless of age, colour, national origin,
citizenship status, physical or mental disability, race, religion, creed,
gender, sex, sexual orientation, gender identity and/or expression, veteran
status, or any other characteristic protected by state or local law. Join us,
and bring the power of your point of view to our culture of collaboration and
innovation. It is through strong diversity, inclusion and engagement that we
can remain a leader in medical technology and solutions. And by embracing
everything you have to offer your unique perspectives, talents and
contributions we can live up to the promise of our Mission.
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.
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