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Sr Clinical Research Specialist

COV Covidien LP
Full-time
Remote friendly (USA-MN Mounds View Central United States of America)

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Senior Clinical Research Specialist (Sr. CRS) in our Surgical Operating Unit, you will have primary responsibility in the execution and oversight of global clinical studies. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. Most of the time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Assumes project management responsibilities for selected studies and site management activities as needed.

Careers that Change Lives

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here

Preferred location(s): Mounds View, MN / Boston, MA / Lafayette, CO / North Haven, CT. Team could consider a candidate to work remotely from the U.S., but will have a strong preference for local/on-site talent.

Ability to travel %. 30% (domestic and international)

A Day in the Life

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

  • Oversees, designs, plans and develops clinical research studies.
    Prepares and authors protocols and patient record forms.
  • Conducts 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 interpret results of clinical investigations in preparation for new drug device or consumer application.
  • Oversees and resolves 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 clinical supply operations, site, and vendor selection.
  • Represents Medtronic from a clinical research perspective 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.
  • Additional tasks as assigned

Other Responsibilities:

  • Autonomy: Seasoned individual contributor.
  • Works independently under limited supervision to determine and develop approach to solutions.
  • Coaches and reviews the work of lower-level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area.
  • Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
  • Makes improvements of processes, systems or products to enhance performance of the job area.
  • Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors.
  • Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
  • May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management.

Must Have: Minimum Requirements

  • Bachelor’s Degree with 4 years of clinical research experience

OR

  • An advanced degree with 2 years of clinical research experience


Nice to Have

  • Degree in engineering, life sciences, or related medical/scientific field
  • 5+ years’ experience managing clinical trials within Medtronic or medical device industry
  • Experience leading an IDE or pre-market study team
  • Experience in Surgical therapies/product
  • Experience managing multiple clinical research sites with proven results in study execution
  • Experience in managing clinical trial data review
  • Basic understanding of biostatistics and trial design
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020


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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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. 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)

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. Learn more about our benefits here.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.​

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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.

Salary ranges for U.S (excl. PR) locations (USD):

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity 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.

At Medtronic, most positions are posted on our career site for 3-7 days.