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Sr Clinical Research Specialist

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Clinical
📅
19000H54 Requisition #
Careers that Change Lives

The Study and Scientific Solutions team is part of the Medtronic Core Clinical Solutions (MC2) Organization which is a centralized function that partners with the Medtronic Business Units to execute Clinical Trials.

A Day in the Life
This Principal Clinical Research Specialist position could consist of three different roles:
  1. A traditional Clinical Trial Leader role managing a clinical research study.
  2. A Medical Writing role for publications, regulatory reports, etc.
  3. A Service Excellence Specialist (SES) role.  The Service Excellence Specialist is an MC2 role designed to assist with the coordination of MC2 functions within a clinical trial. Responsibilities include: creating “flow” and alignment between the MC2 functions and the BU, overcoming silos between MC2 functions, facilitating proactive risk management and helping to increase project efficiencies in order to meet business and study milestones.  This role is the primary focus of this opening and will be the initial assignment.
Responsibilities may include the following and other duties may be assigned.
  • Oversees, designs, plans and develops clinical evaluation research studies.
  • 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 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, and may prepare clinical trial budgets.
  • May be 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.
  • SES Responsibilities:
    • Manages potential risks related to MC2 study deliverables.  Collaborates with MC2 functions and communicates with the BUs to avoid issues on study schedules.
    • Collects MC2-related study concerns/issues and addresses them within the MC2 functions.
    • Advises MC2 functions on improvement opportunities by using deep MC2 cross-functional knowledge.
    • Receives MC2 deliverables and ensures there is proper planning to achieve them on time.  Makes sure deliverables are clearly understood by cross-functional partners.  Sets up check-in meetings with MC2 functions to review deliverables and trigger actions proactively.
    • Creates flow and alignment between MC2 functions by mapping processes, assigning responsibilities, identifying gaps/bottlenecks and opportunities for improvement in the end-to-end process.
Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume. 
  • Bachelors degree required
  • Minimum of 4 years of clinical research experience, or advanced degree with a minimum of 2 years of clinical research experience

Nice to Have
  • Project Management experience
  • Experience with managing deliverables through centralized groups
  • Clinical Trial Management experience

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 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)

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