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Sr Clinical Research Specialist

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Clinical
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19000H25 Requisition #
Location: Plymouth, MN
 
 

Careers That Change Lives

 

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

 

AORTIC AND PERIPHERAL offers treatment for vascular abdominal and thoracic aortic disease and interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies.

 
 
Come for a job, stay for a career. 
 

As a Senior Clinical Research Specialist, you will be accountable for successful and timely completion of studies, and coordination of activities with clinical affiliates in worldwide studies in conformance with applicable federal regulatory requirements where appropriate. 

 
A Day in the Life
 

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

  • 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.
  • May be responsible for clinical supply operations, site and vendor selection.
  • Develops or provides input into the required clinical documents (such as clinical strategy, the Clinical Investigational Plan, study objectives, study budget and project schedule, study training materials, and study reports) in collaboration with investigators and the cross-functional study team to meet business needs.
  • Interfaces with key functional areas in order to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement.)
  • Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes.
  • Facilitates meetings with health care professionals, consultants and internal scientific or tactical committees.
  • Cultivates strong relationship with clinical investigators and site staff. 
  • Evaluates clinical data/ evidence and may determine application of study results.  May provide input and support for planning post-clinical activities, educational activities, and market launch of products
  • May interface with international regulatory agencies including Japan PMDA (Pharmaceuticals and Medical Devices Agency) and prepares and/or conducts presentations to regulatory reviewers regarding requirements and results of the study.
  • Oversees, designs, plans and develops clinical evaluation research studies.
  • Participates in identification of data collection and data reporting requirements to assure clinical study objectives are achievable
  • Collaborates with study leadership team to assure high quality and successful project delivery.
  • Critically evaluates clinical progress and metrics.  May collaborate with cross functional team to identify risks and mitigation plans. 
  • Participates in process improvement initiatives.
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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 or advanced degree with a minimum of 2 years of clinical research experience
Clinical research experience may include industry, corporate, or academic/university research
 

Nice to Have (Preferred Qualifications):

  • 5 years of clinical research experience
  • Bachelor’s degree in clinical or scientific related field
  • Experience in clinical research study processes and/or clinical study design
  • Experience in Good Clinical Practices (GCP) and/or regulatory standards
  • Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
  • Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, CRDM therapies and technologies
  • Project management and critical thinking skills
  • Experience in MS Office applications / word processing, spreadsheets, and/or database applications (e.g., MS Word, Excel, PubMed, etc.)
  • Strong communication skills (efficient, effective, transparent)
  • Strong relationship-building skills (easily builds rapport and trust, influence management skills, collaborative decision making)
 

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 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)

 

Ability to travel 10-20%.


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