Principal Clinical Research Specialist

MedtronicMounds View, MN
Remote

About The Position

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 At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 25% of travel to enhance collaboration and ensure successful completion of projects. In this exciting role as the Principal Clinical Research Specialist (CRS) within the CAS Operating Unit, you will be responsible for driving and overseeing execution of key clinical programs to support the development and advancement of best-in-class ablation therapies. The Principal 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 Senior 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 Principal Clinical Research Specialist will collaborate with other members of the CAS leadership team, as well as other cross-functional stakeholders (e.g., Research and Development, Corporate Biostats, Regulatory Affairs, Clinical IT, and others). In this role, you will collaborates, build relationships, and communicates effectively with a large group of internal and external stakeholders in a rapidly changing landscape, while managing the timely completion of deliverables. This role has a high-level of visibility to senior leaders at Medtronic including Executive Committee members and senior clinical leaders across all OUs.

Requirements

  • Bachelor's degree
  • Minimum of 7 years of clinical research experience Or Advanced degree with 5 years of clinical research experience
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
  • U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs.

Nice To Haves

  • Degree in life sciences, or related medical/scientific field.
  • Experience conducting/working on clinical studies and managing clinical trial data review
  • Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
  • CCRA certification (Certified Clinical Research Association) or SOCRA.
  • Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
  • Experience with Clinical Operations and interfacing with CRO teams.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Excellent project management and organization skills.

Responsibilities

  • Driving and overseeing execution of key clinical programs to support the development and advancement of best-in-class ablation therapies.
  • 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.
  • Setting work direction for the study team and owning the study data to ensure that all data collected is comprehensive, accurate, and up to date.
  • Collaborating with other members of the CAS leadership team, as well as other cross-functional stakeholders (e.g., Research and Development, Corporate Biostats, Regulatory Affairs, Clinical IT, and others).
  • Collaborating, building relationships, and communicating effectively with a large group of internal and external stakeholders in a rapidly changing landscape, while managing the timely completion of deliverables.

Benefits

  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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