Principal Clinical Research Specialist
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BASIC QUALIFICATIONS:
• Bachelor’s degree
• 7+ years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable OR MS, MA, or MPH with 5+ years experience or PharmD, PhD, DVM, or MD with 3+ years experience supporting clinical research
DESIRED/PREFERRED QUALIFICATIONS:
• Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
• Experience managing clinical trials from start to finish.
• Experience managing cardiovascular medical device and/or pharmaceutical trials
• 3+ years of previous study management
• Previous personnel management and/or previous experience providing work direction to staff and accomplishing study execution through others.
• Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field).
• Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals
• Experience facilitating committees (e.g. Clinical Events Committee, Data Safety Monitoring Board, Adverse Events Advisory Committee, etc.) and/or managing vendors (e.g. Contract Research Organizations, Core Laboratories, etc.)
• Experience working with Microsoft Word, Excel, PowerPoint and familiarity with web-based applications
• Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness.
• Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
• Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
• Willingness to accept challenging assignments and engage in relevant developmental activities
• Proficient knowledge of medical terminology
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
• Demonstrated ability to clearly and effectively communicate verbally and in writing
• High attention to detail and accuracy
• Exceptional project management capabilities and proficient use of project management tools
PHYSICAL JOB REQUIREMENTS
• 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.
• 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.
• Ability to travel 20-30% of the time.
PHYSICAL JOB REQUIREMENTS:
MEDTRONIC OVERVIEW:
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 exciting and rewarding place to be.
We can 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.
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
