28 days old

Sr Clinical Research Manager (Surgical Innovations)

Mansfield, MA 02048
Sr Clinical Research Manager (Surgical Innovations)


New Haven, Connecticut, United States

Requisition #:


Post Date:

Jan 15, 2020

Haven, CT or remote within the U.S.

**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 Senior Clinical Research Manager, you will work in a dynamic cross functional
setting to drive medical device innovation through product development
oversight, global evidence strategy creation and portfolio management.

Come for a job, stay for
a career.

The **MinimallyInvasive Therapies Group (MITG)** strives to enable earlier diagnosis,
better treatment, faster complication-free recovery, and enhanced patient
outcomes through less invasive surgical solutions.

**SURGICALINNOVATIONS** sets the standard for
Minimally Invasive Surgery (MIS) by creating innovative surgical products and
services that focus on obesity and diseases and conditions of the
gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and

**A Day in the Life**

The Senior Clinical
Research Manager will support new product development and lifecycle management
activities through the evidence portfolio, talent development, and
functional/operational excellence.This person will oversee global
clinical evidence strategies and serve as a representative on product development
governance bodies for one or more RD sites within the Surgical Innovations
portfolio. Responsible for independently managing day-to-day activities
including global evidence strategy creation, generation of clinical evidence
plans and clinical protocol synopses, post market clinical follow up plans and
reports, and clinical evaluation reports. Ensures that product lines have the
right evidence to gain/maintain global registration and adoption. This position
requires strong leadership skills and the ability to manage people, deliver on
clinical deliverables, and align with business initiatives. This person must
possess strong presentation, communication (oral and written), and leadership
skills and develop internal and external customer relationships. This
person will develop and motivate their team and adhere to training, quality,
and compliance requirements.

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

+ Oversees the Global Clinical Strategy for a class oftrade(s) within the Surgical Innovations portfolio, including relatedRD projects in the pipeline

+ Ensures successful creation of clinical plansconsistent with business objectives and applicable regulations andpolicies

+ Develops evidence strategies to obtain timely productapprovals from worldwide regulatory bodies.

+ Manage Clinical Research participation in early productdefinition, planning, and product lifecycle management, including definingnew markets and uses for Surgical Innovations products (Pre-PD)

+ Serve as Clinical Research representative on siteproduct development governance bodies

+ Maintain knowledge of competitive or state-of-the-arttechnologies and applicable regulatory requirements. Ensures that staffreceives relevant training in applicable medical, technical, andbiomedical training specific to their assigned business projects.

+ Oversee Clinical Research review of training materials,external communications, and marketing collateral for current and futureproduct lines.

+ Responsible for developing and leading the ClinicalStrategy staff at one or more Medtronic locations

+ Coordinate process improvement initiatives, taskforces,and committees within Clinical Research and cross-functionally.

+ Ensures quality of clinical protocols, ClinicalEvidence Plans, Post Market Clinical Follow Up Plans and Reports, GlobalEvidence Strategies, and Clinical Evaluation Reports

+ May serve as CAPA or Audit champion

+ Builds and maintains a strong network and closerelationship with the various internal and external parties.

**Must Have (Minimum Requirements):**

**Tobe considered for this role, the minimum requirements must be evident on yourresume.**

+ Bachelors degree required and a minimum of **7** years of experience in clinical research/medical affairs with 5+ years of managerial experience, or advanced degree with a minimum of **5** years of experience in clinical research/medical affairs with 5+ years of managerial experience.

**Nice to Have (PreferredQualifications):**

+ Advanced Degree MS or PhD or MD.

+ 8+ years experience in medical device industryclinical trials.

+ Cost-center/budget management experience.

+ Familiar with Medical Device and/or combination producttrials and regulations.

+ Proficient knowledge of medical terminology.

+ Expertise withGood Clinical Practice (GCPs) and regulatoryand compliance guidelines for clinical trials.

+ Product development experience including globalclinical strategy development

+ Significant knowledge of clinical and outcomes researchstudy design.

+ Demonstrated ability to work effectively on cross-functionalteams.

+ Experience managing direct reports in variouslocations.

+ Leadership skills include strong communication, problemsolving, quality focus, business integration acumen, and changemanagement.

+ Experience in a high demand and fast-paced environment.

**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

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)

Travel between 25-50%.
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.


Posted: 2020-01-21 Expires: 2020-02-23

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Sr Clinical Research Manager (Surgical Innovations)

Mansfield, MA 02048

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