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.
Responsibilities:
Oversees, designs, plans, and develops clinical research studies for products that are under Clinical Investigation.
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 device or consumer application.
Oversees and manages 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
Prepares and manages clinical trial budgets.
Serves as liaison between program management and planning, study team, and leadership
Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others
Reviews status of projects and budgets; manages schedules and prepares status reports.
Responsible for clinical supply operations, site and vendor selection.
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 optimal relationships and effective collaborations with various internal and external parties.
Drives local evidence dissemination & awareness.
Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
Bachelor’s degree required with a minimum of 4 years of clinical research experience (i.e., in the development and execution of clinical studies) or advanced degree with a minimum of 2 years of clinical research experience (i.e., in the development and execution of clinical studies)
Nice to Have (Preferred Qualifications):
Degree in engineering, life sciences, or related medical/scientific field
Clinical Research experience at Medtronic or within a medical device industry
Experience developing clinical strategies and study design
Experience in Peripheral or Endovenous therapies/product
Experience working on a global study team
Basic understanding of biostatistics and trial design
Experience in Research and Development (R&D)
Project/program management skills/experience
Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
Experience in Research and Development (R&D)
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
Proficient in MS Office applications: Excel, PowerPoint, Word, MS Project (or similar scheduling software), project management techniques and tools.
Expertise in both theoretical and practical aspects of project management
PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification
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.
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.
Medtronic benefits and compensation plans
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.