Role Description
In this exciting role as a Senior Clinical Research Specialist (Sr. CRS) in our Surgical Operating Unit, you will have primary responsibility in the execution and oversight of global clinical studies. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. Most of the time is spent delivering and overseeing the projects β from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Assumes project management responsibilities for selected studies and site management activities as needed.
Responsibilities may include the following and other duties may be assigned:
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Oversees, designs, plans and develops clinical evaluation research studies.
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Prepares and authors protocols and patient record forms.
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Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
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Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application.
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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.
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May be responsible for clinical supply operations, site and vendor selection.
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Represents Medtronic from a clinical research perspective within the country/region and also collects feedback from local customers and authorities.
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Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
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Drives local evidence dissemination & awareness.
Qualifications
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Bachelorβs degree required.
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Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
Requirements
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Knowledge of Medtronic systems.
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Understanding of the clinical Quality and Regulatory environments.
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Experience in the Medical Device Industry.
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For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. Β§ 214.2(h)(4)(iii)(A) is required.
Benefits
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Medtronic offers a competitive Salary and flexible Benefits Package.
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A commitment to our employees lives at the core of our values.
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Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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Salary ranges for U.S (excl. PR) locations (USD): $105,600.00 - $158,400.00.
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This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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Health, Dental and vision insurance.
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Health Savings Account.
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Healthcare Flexible Spending Account.
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Life insurance, Long-term disability leave.
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Dependent daycare spending account.
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Tuition assistance/reimbursement.
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Simple Steps (global well-being program).
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Incentive plans, 401(k) plan plus employer contribution and match.
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Short-term disability.
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Paid time off.
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Paid holidays.
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Employee Stock Purchase Plan.
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Employee Assistance Program.
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Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
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Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).