Principal Clinical Research Specialist EPT
Mounds View, MN - USA
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were 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.
Responsibilities may include the following and other duties may be assigned.
- 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
Must Have (Minimum Requirements):
To be considered for this role the minimum requirements must be evident on your resume.
- Bachelors degree
- Minimum of 7 years of clinical research experience or Advanced degree with 5 years of clinical research experience
Nice to Have (Preferred Qualifications):
- 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 incardiovasculararea
- 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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach 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. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 excit ... View more