Senior Clinical Research Specialist - Diabetes Northridge CA or remote within US

Profile

**Careers That Change Lives**
In this exciting role as a Senior Clinical Research Specialist (CRS), you will have primary focus responsibility leading study management projects for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. You will oversee, design, plan and develop clinical projects for assigned clinical programs and work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Under direct supervision, assumes project management responsibilities for selected studies and site management activities as needed.
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its 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 (****Remote within the United States (preferred location is Northridge, CA)
Travel up to 10-15%.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Oversees, designs, plans and develops clinical evaluation research studies.
Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
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, and may prepare clinical trial budgets.
Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
Responsible for overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
Participates in overall clinical management plan, protocol and case report form development.
Responsible for site initiation activities, resolution and follow-up of site issues, and study closure activities. May be responsible for clinical supply operations, site and vendor selection.
Provides support and training for clinical study sites to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
Performs data review, reviews data discrepancies, generates reports. May assist with publication of study data in medical literature and/or presentation at scientific meetings
May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.
Assists clinical management with other duties as requested.
May be responsible for clinical supply operations, site and vendor selection.
**Must Have (Minimum Requirements):**
**To be considered for this role, the minimum requirements listed below must be evident on your resume.**
Bachelor's degree and a minimum of 4 years of clinical research experience or advanced degree with 2 years of clinical research experience
**Nice to Have (Preferred Qualifications):**
Master's degree in Engineering, Biomedical Sciences, or related medical/scientific field.
CCRA certification (Certified Clinical Research Association); SOCRA.
Clinical Research experience at Medtronic or within a medical device industry, preferably in Diabetes area
Experience in Diabetes therapies/products
Experience in managing clinical trials and data review.
Experience in managing multiple clinical research sites with proven results in study execution.
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.
Clinical study management experience
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
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. Lets 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.
Learn more about our benefits at **benefits.medtronic.com**
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Categories
Healthcare
Biotechnology / Science
Sales / Business Development
Manufacturing / Production
Engineering
Marketing
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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