Description
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**
**Careers That Change Lives**
In this exciting role as a?Senior Clinical Research Specialist (CRS)?you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. ?You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.
This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.
**Peripheral Vascular Health Operating Unit**
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader - that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.??
To learn more about Inclusion & Diversity at Medtronic?Click Here ()
Location:? Remote within the U. S; preferred location(s): Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN
Ability to travel up to 25% (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 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 maintainsoptimal relationships and effective collaborations with various internal and external parties.
Drives local evidence dissemination & awareness.?
Other Responsibilities:
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
**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. I
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