Principal Clinical Research Specialist - EPT

Medtronic • Mounds View, MN

1d • Onsite

About The Position

The Electro Physiology Technologies business unit is focused on advancing innovative solutions that support the diagnosis and treatment of cardiac rhythm disorders. The team works collaboratively to develop, deliver, and improve technologies that help clinicians provide effective patient care. Operating in a fast-paced, highly regulated environment, the business unit emphasizes quality, innovation, cross-functional partnership, and continuous improvement to support both customer needs and long-term business success. 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. 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 Principal 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

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

• Establish, develop, and foster solid relationships with Key Opinion Leaders (KOLs) and internal business partners.
• Partner with National Principal Investigators, clinical site investigators and physician KOLs to develop and execute publication strategies and plans.
• Lead key scientific abstract, manuscript, poster presentation, oral presentation, and late-breaking trial presentation development and submission in compliance with Medtronic SOPs and external ICMJE, GPP3, and scientific conference guidelines.
• Manage portfolio of publication activities on assigned projects (e.g. collect input on strategic alignment, drive commitment decisions, communicate decisions to investigators).
• Create and manage the project schedule for each deliverable through final delivery (e.g. peer-review publication, scientific conference presentation) while in compliance to regulatory, medical society, and corporate standards.
• Evaluate and analyze clinical data.
• Own or co-own the publication plan, and serve as a subject matter expert on a variety of scientific materials.
• Develop impactful publication plans and represent the Publications team in congress planning team meetings to ensure optimization of evidence distribution strategy and delivery of consistent scientific messages.
• Monitor all major scientific congresses for abstract deadlines and work with investigators of Medtronic sponsored research to drive podium presence in support of corporate scientific communication strategies and plans.
• Attend key scientific congresses and drive execution of business-related publications activities prior to, on-site, and post congresses; including management of speaker preparation and scientific session coverage and report-out.
• Serve as liaison between program management and planning, study team, and leadership.
• Perform literature searches and reviews to support evidence needs and strategies.
• Develop methods to track and measure impact of publications.
• Work with clinical study team(s) on data timelines to create long-term forecasting for data availability.
• Oversee and interpret results of clinical investigations in preparation for new device or consumer application.
• Collaborate closely with medical affairs, regulatory, marketing, and other functions to gather feedback and communicate status updates.
• Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal