Senior Clinical Research Specialist - CAS

MedtronicMounds View, MN
2dOnsite

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 Cardiac Ablation Solutions (CAS) offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. Ability to travel up to 25% domestic and international In this exciting role as the Senior 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 Senior 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 Senior 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 4 years of clinical research experience
  • Or Advanced degree with 2 years of clinical research experience

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.
  • 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.

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
  • 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
  • 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)
  • 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

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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