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Sr Clinical Research Specialist

📁
Clinical
📅
19000GDJ Requisition #
Location: Boulder, CO
 

Careers That Change Lives

 

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

The Sr Clinical Research Specialist (CRS) is responsible for overseeing and executing post market clinical programs for the Respiratory and Monitoring Solutions franchise. The Sr CRS is responsible for developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The Sr. CRS sets work direction for the study team and owns the study data to ensure that all data collected is comprehensive, accurate, and up to date. The Sr Clinical Research Specialist will ensure timely deployment of post-market clinical research projects and delivery of meaningful data to support the general safety and performance requirements for all medical devices across the Respiratory and Monitoring Solutions Franchises. 

 
Come for a job, stay for a career. 


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

PATIENT MONITORING AND RECOVERY focuses on improving outcomes associated with respiratory compromise, deep vein thrombosis, nutritional insufficiency, and healthcare associated infections. 

EARLY TECHNOLOGIES provide innovative solutions that improve patient outcomes, lower the cost of healthcare delivery, and expand global access to care for cancers and chronic diseases of the GI tract, liver, and lung.

RENAL CARE SOLUTIONS strives to improve outcomes, access, and quality of life for patients affected by renal disease.

 
A Day in the Life
 

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

  • Oversees, designs, plans and develops clinical evaluation research studies and projects. 
  • Prepares and authors protocols and case report 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 resolves operational aspects of clinical projects 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 to support Post Market Clinical Follow Up requirements.
  • Oversees clinical study/project operations, including safety, monitoring, data management, and site and vendor selection.
  • Sets work direction for the study team including delegation and oversight of tasks.
  • Escalates any study issues quickly to leadership and ensures study milestones are met.
  • Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
  • Drives local evidence dissemination & awareness.

Cross Functional Collaboration

  • Build influential partnerships across Respiratory and Monitoring Solutions Franchises, including cross-functional Regulatory, Clinical, and Regional Marketing, to ensure the successful deployment and analysis of post-market clinical follow-up activities
  • Build relationships across the larger MITG, and greater Medtronic organization to leverage existing processes, systems and vendors to fulfill post-market clinical follow-up requirements
  • Contribute to an environment of collaboration, trust, achievement and high engagement.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

The Sr Clinical Research Specialist, Respiratory and Monitoring Solutions, reports to the Sr. Clinical PRogram Manager, Respiratory, Gastrointestinal and Informatics (RGI) and will play a key leadership role for implementation of clinical activities across the Respiratory and Monitoring Solutions Franchises, to ensure compliance with the EU MDR.

The Sr Clinical Research Specialist will work with regional functional counterparts (Marketing, Clinical, Regional Country Clinical, Medical Affairs, and Regulatory Affairs) to ensure proper communication and alignment on all post-market clinical follow-up activities.

 
Other Responsibilities:
  • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and management.
  • Reviews status of projects and budgets; manages schedules and prepares status reports.
  • Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
  • Develops mechanisms for monitoring project progress and for intervention and problem solving
  • Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.

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
 

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 working on a Global study team
  • Experience influencing teams and working in a matrix organization.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Experience in managing clinical trial data review.
  • Ability to incorporate and adhere to good clinical practices and regulatory standards.
  • Ability to manage multiple clinical research sites with proven results in study execution.
  • Ability to identify and implement solutions in addressing study issues.
  • Basic understanding of biostatistics and trial design.
  • Proficient knowledge of medical terminology.
  • Strong and on-time execution focus with stakeholders including Clinical and Regulatory Affairs in a dynamic environment with an ability to be agile. 
  • Understanding of the timeline and requirements for implementation of the EU MDR as it pertains to general safety and performance requirements.
  • Strong quantitative, analytical, written and verbal skills. 
  • Proven track record of planning and execution. 
  • Excellent project management and organization 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. 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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