Clinical Research Program Manager Aortic Remote within the U.S.

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**Careers That Change Lives**
In this exciting role as a Clinical Research Program Manager in the Structural Heart and Aortic integrated operating unit, you will be responsible for leading clinical research programs and activities in support of new and existing Aortic products and therapies to achieve regulatory approval and establish comprehensive clinical evidence. You will help to drive innovation through cross-functional engagement in product development and evidence core teams. This position will report directly to the Aortic OU Clinical leader.
The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valvesaortic, pulmonic, mitral, tricuspidand the placement of stent grafts to treat aneurysms and dissections of the bodys largest artery, the aorta.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its 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 (****.
Location: Remote within U.S.; preferred locations: Minnesota or Santa Rosa, CA
Ability to travel up to 25%, domestically and internationally
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Develops and implements clinical/regulatory strategies to obtain timely product approvals from worldwide regulatory bodies.
Leads development and implementation of overall clinical evidence strategies for medical device product(s).
Provides clinical subject matter expertise on product development project (PDP) core teams.
Interacts and works cross-functionally with other departments, including but not limited to Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, R&D, and regions (US and OUS) to ensure program execution to achieve business goals.
Represents Medtronic from a clinical research perspective within the country / region and also collects feedback from customers and regulatory authorities.
Provides strategic and operational oversight of global clinical studies.
Ensures clinical portions of regulatory submissions are accurately prepared and comply with regulatory requirements.
Establishes improved structures and processes, serving as a role model in demonstrating collaborative behaviors and a boundary-less mindset.
Supports clinical goals, strategies, plans and objectives. Regularly reviews clinical metrics against objectives and takes actions to assess deviations from the plans, as/where necessary. Drives the clinical organization to meet or exceed objectives. Communicates with senior management on progress, barriers, and potential solutions.
Works within and actively promotes Medtronics core mission, corporate strategies, policies, procedures and Code of Conduct.
**Must Have (Minimum Requirements):**
**To be considered for this role, the minimum requirements must be evident on your resume.**
Bachelors degree required with a minimum of 5 years of clinical research with project/program management experience or skills, or advanced degree with a minimum of 3 years of clinical research project/program management experience or skills
**Nice to Have (Preferred Qualifications):**
Advanced degree in engineering, life sciences, or related medical/scientific field
Clinical research experience at Medtronic or within the medical device industry
Global clinical trial management experience and/or experience managing projects in a global scope
Experience developing and executing strategy
Experience working in a cross-functional environment, with R&D, Regulatory, and International functions
Basic understanding of biostatistics and trial design
Experience working with and influencing clinicians and regulatory stakeholders
Experience with clinical research methodologies as well as understanding global regulations and policies
Experience with budgeting and working with Finance
Proficiency with writing reports, business correspondence, and clinical research documents with advanced written, presentation and oral communications skills
**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).
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 at benefits.medtronic.com**
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
Healthcare
Biotechnology / Science
Management
Engineering
Marketing
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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