Senior Clinical Research Specialist Post Approval Clinical Surveillance PACS - Minneapolis MN or remote within the US

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**Careers That Change Lives**
The Senior Clinical Research Specialist (Sr. CRS) is responsible for the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. With minimal supervision, the Sr. CRS will assume project management responsibilities for assigned studies and will be responsible and accountable for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. The **Post Approval Clinical Surveillance** team is recognized as an enterprise leader for cost effective global post market clinical surveillance methodologies and strategies to guide the generation of world class evidence and fulfill the Medtronic Mission. Current evidence needs have created increased need to report clinical data and the group is experiencing significant growth.
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 (****Ability to travel 10-20% in the USA.
Location: Minneapolis, MN (OHQ); open for remote location.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Responsible for the overall conduct and execution of a study (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans) to ensure all study deliverables are on track
Initiates, coordinates and is responsible for developing study materials (e.g., protocol, informed consent, case report forms, training, etc.) in compliance with regulatory requirements, standard operating procedures (SOP), and alignment with study objectives
Acts as the primary contact for site personnel to complete study initiation requirements and ensure protocol compliance, achievement of data quality metrics and deliverables, regulatory requirements, and good clinical practices
Oversee activities and provides work direction for extended team members including (e.g., project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, SOPs, and appropriate regulations and guidelines
Oversee follow-up and resolution of sites issues
Proactively identifies and mitigates quality risk and/or issues associated with assigned studies/activities
Conduct training of study site and/or Medtronic staff
Other Responsibilities _:_
Assist in the preparation of budgets
Prepare study reports, regulatory submissions, publications and/or presentations
Participates in multidisciplinary taskforces to support continuous improvement initiatives
**Must Have (Minimum Requirements):**
**To be considered for this role, the minimum requirements must be evident on your resume.**
Bachelors degree required with a minimum of **4** years of clinical research experience or advanced degree with a minimum of **2** years of clinical research experience
**Nice to Have (Preferred Qualifications):**
Degree in engineering, life sciences, or related medical/scientific field
Clinical Research experience at Medtronic or within a medical device industry
Experience managing multiple clinical research studies with proven results in study execution
Experience working on a Global study team
Experience in identifying and implementing solutions in addressing study issues
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials. Ability to incorporate and adhere to good clinical practices and regulatory standard
Experience in managing clinical trial data review
Basic understanding of biostatistics and trial design
Proficient knowledge of medical terminology
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)
Ability to travel 10-20%.
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
Engineering
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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