1+ months

Clinical Research Manager

Medtronic
Boston, MA 02133
Clinical Research Manager

Location:

Framingham, Massachusetts, United States

Requisition #:

19000NVN

Post Date:

Dec 20, 2019


**Location:** This position will be located in Boston.


**Careers That ChangeLives**


Help lead the effort to
create global strategies for worldwide medical device approvals to introduce
new products to market.


In this exciting role as
a Clinical Research Manager, you will have primary responsibility to manage 7
direct reports and 8-10 clinical studies across the MCS (Mechanical Circulatory
Support) business focusing on the evidence portfolio, talent development, and
functional/operational excellence.


Come for a job, stay for
a career.


Cardiac and Vascular
Group (CVG)


The Cardiac and Vascular
Group brings all of our cardiac and vascular businesses together into one
cross-functional, collaborative operating unit to employ the full breadth of
our talent, technologies, products, services, and solutions to address the
needs of customers and patients across the globe. This group includes Aortic,
Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial
Fibrillation (AF) Solutions, and Coronary and Structural Heart products.


Within CVG,
theCardiac Rhythm and Heart Failure (CRHF) offers devices and therapies
to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.


**A Day in the Life**


The Clinical Research
Manager will lead a small team supporting clinical studies in the MCS business focusing
on the evidence portfolio, talent development, and functional/operational
excellence. This person will oversee study project plans, quality,
execution, and financial management. Responsible for independently managing
day-to-day activities including trial start-up, conduct, and closeout
activities on (multiple) clinical trials of moderate to high complexity, or
managing a broader range of activities on large multi-center studies and is
expected to address and manage site, CRA and vendor related issues, with
assistance as needed. This position requires strong leadership skills and
the ability to manage people, deliver on clinical projects, and align with MCS
Business initiatives. This person must possess strong presentation, communication
(oral and written), influence management, relationship (both internal and
customer) and leadership skills. This person will develop and motivate
their team and adhere to training, quality, and compliance requirements.
This person will also help lead functional improvement projects across the
clinical portfolio.


Responsibilities may
include the following and other duties may be assigned.


+ Provides leadership for theconduct of clinical studies and for the regulatory affairs function as itapplies to product approval.

+ Studies must be scientificallyvalid, meet all relevant regulatory requirements and be conducted withinethical guidelines aligned with the functional and business evidencestrategy.

+ The end result of the clinicalstudies must be a fair assessment of the safety and efficacy of the testedproduct (s) and completion of evidence efforts must be done in a timelymatter and on budget with appropriate resources.

+ Ensures regulatory submissionsare accurately prepared and comply with regulatory approvals.

+ Represents Medtronic from aclinical research perspective within the country / region and alsocollects feedback from local customers and authorities.

+ Builds and maintains a strongnetwork and close relationship with the various internal and externalparties.

+ Leads execution for both localand global studies, manages clinical research projects focused on MCSstudies across the CRHF portfolio.

+ May be assigned as a clinicalmember of a product core team

+ Provides direction to directreports on general policies and management guidance, mentoring,objectives, and performance reviews

+ Maintain team development opportunities,engagement, and training compliance

+ Responsible for functionalprojects that add value to the clinical portfolio including trying newprocess improvements, system enhancements, and innovative resourcing.

+ Ability to navigatematrix organizations across geographies, functions, and business units

+ Peoplemanagement with 6-7 direct reports (local and remote Clinical ResearchSpecialists).


**Must Have (MinimumRequirements):**


**To be considered for this role, the minimum requirements must beevident on your resume.**


+ Bachelors degree required anda minimum of 5 years of experience managing/leading clinicalstudies/trials, or advanced degree with a minimum of 3 years of experiencemanaging/leading clinical studies/trials


**Nice to Have (Preferred Qualifications):**


+ Advanced Degree MS or PhD orMD.

+ 5+ years experience in device,biotechnical and/or pharmaceutical industry clinical trials.

+ Peoplemanagement experience / experience as a Clinical Research Manager withdirect reports.

+ Cost-center/budget managementexperience.

+ Familiar with Medical Deviceand/or combination product trials and regulations.

+ Proficient knowledge of medicalterminology.

+ Expertise withGoodClinical Practice (GCPs) and regulatory and compliance guidelines forclinical trials.

+ Significant knowledge ofclinical and outcomes research study design.

+ Demonstrated ability to workeffectively on cross-functional teams.

+ Oracle Electronic Data Captureexperience.

+ Siebel Clinical TrialManagement System experience.

+ Experience in conductingclinical trials in cardiovascular therapeutic indications.

+ Leadership skills includestrong communication, problem solving, quality focus, business integrationacumen, and change management.

+ Experience in a high demand andfast-paced environment.

+ Experience working with earlytechnologies

+ Experience with innovativeapproaches to study design and execution


**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 the future.


**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.
(ADA-United States of America)


Ability to travel up to 25%.
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: 2019-12-05 Expires: 2020-01-30

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Clinical Research Manager

Medtronic
Boston, MA 02133

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