Senior Manager, Clinical Research - Structural Heart
Company: Medtronic GmbH
Location: Costa Mesa
Posted on: February 25, 2021
Senior Manager, Clinical Research - Structural Heart In this
exciting role as a Senior Manager, Clinical Research (Sr CRM), you
will have primary focus responsibility to oversee all clinical
activities related to one or more clinical studies and
performing/managing the daily in-house activities associated with
the studies. This is a managerial role. The Sr CRM will report to
the Clinical Research Director and independently handle various
clinical study assignments, have management responsibility, and
oversees and directs the work of a team of Clinical Research
Managers, Principal Clinical Research Associates, Sr Clinical
Research Associates, Clinical Research Assistants, and/or Project
Coordinators as required. The Structural Heart Business is one of
the fastest growing businesses and helps patients all over the
globe needing valve replacement.--
We look for leaders who have a clear vision of where we are going
and how to get there, bold inclusive thinkers who create new ideas
and bring our best solutions forward to benefit our patients,
business partners, and customers. This role reports to the leader
of Medtronic Clinical Programs for Mitral and Tricuspid Therapies.
This role is responsible for providing daily oversight/management
of operations and execution of deliverables as well as to develop
and implement strategies to enhance the capabilities and
performance of the organization. You'll always have new challenges
pursuing ideas that are exciting, innovative, and just plain cool.
Build out the future of robotic healthcare. Think critically about
healthcare problems and/or opportunities to advance science faster
than others. Do research on improving the healthcare of millions.--
We believe that when people from different cultures, genders, and
points of view come together, innovation is the result - and
everyone wins. Medtronic walks the walk, creating an inclusive
culture where you can thrive. Primary location is Mounds View, MN;
would consider remote. Travel up to 25% (domestic and may include
international travel). A Day in the Life Responsibilities may
include the following and other duties may be assigned.
- Provides leadership for the conduct of clinical studies and in
the development of clinical evidence for pre an post-market
trials/studies as it applies to product lifecycle.
- Studies must be scientifically valid, meet all relevant
regulatory requirements and be conducted within ethical
- The end result of the clinical studies must be a fair
assessment of the safety and efficacy of the tested product (s) and
attainment of product approvals in a timely matter.
- Develops and implements regulatory strategies to obtain timely
product approvals form worldwide regulatory bodies.
- Ensures regulatory submissions are accurately prepared and
comply with regulatory approvals.
- 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 a strong network and close relationship
with the various internal and external parties.
- Leads execution for both local and global studies, manages
clinical research projects over all of the Medtronic therapies
across multiple businesses.
- Responsible for conducting clinical programs consistent with
applicable regulations, guidelines, and policies. Research,
prepare, and revise the Investigational Plan (study protocol,
Instructions For Use (IFU), report of prior Investigations,
bibliography, Case Report Forms (CRFs), etc.) and other appropriate
sections of the Investigational Device Exemption (IDE) in
consultation with the cross-functional project team, investigators,
data management, and biostatistics.
- Provides management review and approval of relevant clinical
documents. Supervise training of investigators, site staff, and
Medtronic clinical staff. Supervise site initiation
- Oversee accuracy of clinical studies/projects.
- Develop and manage cost center budget and study budgets.
- Ensures appropriate resources and priorities are maintained for
the various projects assigned to their area. Oversees Clinical
Research staff with all aspects of their responsibilities. May
interface with regulatory agencies, as appropriate.
- Collaborate with Clinical Operations department to coordinate
field staff and clinical site activities with study needs. Compile,
review, and conclude device complaints. Provide management level
representation during audits.
- Performs personnel related supervisory duties (e.g.,
performance assessments, development of staff goals and
objectives). Assist data management group with review of clinical
data/information and provide oversight of data correction.
- Interfaces with representatives from key functional groups
(Research & Development, Manufacturing, Sales, Marketing,
Regulatory Affairs, and European Clinical Groups) to drive clinical
wide or cross-departmental initiatives.
- Work with Clinical Customer Service to control device
allocation, distribution, and reconciliation. Manages activities
performed by Contract Research Organizations (e.g. CROs, core
- Oversees the clinical department SOP/DOP review and
development, employee training, and associated requirements.
Evaluate clinical data/information, write, and revise annual,
interim, and final reports and clinical sections of Pre-Market
Approval (PMA) submissions.
- May organize and direct investigator conferences to review
findings and advise on study direction, as needed.
- Provide input and support for post-clinical activities and
market launch of products. May co-author results of studies for
medical literature and/or presentations at scientific meetings.
Must Have (Minimum Requirements): To be considered for this role,
the minimum requirements must be evident on your resume.
- Bachelor's degree required and minimum of--7--years of clinical
research experience with 5+ years of managerial experience, or
advanced degree and minimum of--5--years of clinical research
experience with--5+ years of managerial experience *
Managerial/leadership experience (i.e., experience as a manager
having direct or indirect reports, people leader) Nice to Have
- Advanced degree (Masters, PhD or MD) preferred. Technical
degree defined as engineering, life sciences or related
- 7+ years' experience managing multiple clinical research
studies--at Medtronic--or in medical device industry
- Experience managing cardiovascular medical device
- Experience--managing direct reports and leading clinical teams.
Cost-center/budget management experience.
- Experience in medical device clinical product trials and
- Expertise with--Good Clinical Practice (GCPs) and regulatory
and compliance guidelines for clinical trials
- Experience in clinical trial design, as well as managing
clinical trials from start to finish.
- Global clinical trial strategy and execution, and outcomes
research study design.
- Product development experience including global clinical
- Leadership skills include strong communication, problem
solving, quality focus, business integration acumen, and change
- Demonstrated ability to work effectively globally on
- Experience in a high-demand and fast-paced environment.-- About
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. Let's 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). Travel up to 25%. Check out benefits.medtronic.com 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. This position is eligible for a short-term
incentive plan. Learn more about Annual Salary and Medtronic
Incentive Plan (MIP) on Page 6 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. This employer participates in the federal E-Verify
program to confirm the identity and employment authorization of all
newly hired employees. For further information about the E-Verify
program, please click here .
Keywords: Medtronic GmbH, Costa Mesa , Senior Manager, Clinical Research - Structural Heart, Healthcare , Costa Mesa, California
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