Description
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**
Key responsibilities
**Careers That Change Lives**
In this exciting role as a Sr. Clinical Research Specialist, you will have primary focus responsibility to assist with Clinical Evaluation Reports (CERs) to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical evidence dissemination and post-market clinical surveillance. This candidate will work within the Clinical team to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies and continued market approvals. This medical writer will be responsible for clinical product management with regards to governmental agency filings, including Medical Devices Directive (MDD) and Medical Device Regulation (MDR) submissions.
The Cardiac Ablation Solutions (CAS) business is one of the fastest growing businesses and helps patients all over the globe requiring mapping and ablation for cardiac arrhythmias. The Cardiac Ablation Solutions Operating Unit focuses on Arrythmia disease management (including Atrial Fibrillation).
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here () .
Primary business location is Mounds View, MN; will consider remote position within the United States.
Travel up to 20%.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Oversees, designs, plans, and develops Clinical Evaluation Reports (CERs) for governmental agencies in support of post-market requirements and regulations.
Evaluates and summarizes clinical data/evidence for clinical reports, obtaining input and alignment from key stakeholders.
May interface with national-level regulatory agencies including meetings and prepares and/or conducts presentations to panel reviewers regarding requirements and results of the study.
Review data from internal clinical studies and external literature in support of continued product approvals.
May have core team responsibilities including product approval strategies, continued clinical evidence landscaping, and clinical claims requirements.
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.
Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
Assists with overall successful conduct of assigned clinical projects consistent with applicable regulations, guidelines, and policies
Participates in overall clinical management plan, protocol and case report form development.
Provides support and training for clinical teams, physicians, and cross-functional partners to assure data integrity and protocol compliance.
May interface with representatives from key functional groups including Product Development, Therapy Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs
Assists clinical management with other duties as requested
**Must Have (Minimum Requirements):**
**To be considered for this role, the minimum requirements must be evident on your resume.**
Bachelor's degree
Minimum of 4 years of clinical research experience
OR
Advanced degree with 2 years of clinical research experience
**Nice to Have (Preferred Qualifications):**
Degree in life sciences, or related medical/scientific field.
Experience conducting/working on Clinical Evaluation Reports (CERs) for governmental agencies.
Knowledge ofMedical Devices Directive (MDD) and Medical Device Regulation (MDR).
Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area.
Strong knowledge of clinical and regulatory agency filings including pre-market and post-market requirements.
Experience with Clinical Operations and interfacing with Clinical and Regulatory teams.
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
Excellent project management and organization skills.
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
**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. (ADA-United States of America).
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.<
Compensation Information:
$0.0 / - $0.0 /
Starting At: 0.0
Up To: 0.0
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