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For your reference, we have included the original job posting below.
Prin Clinical Research Spec Job
Job Number:
25300445
Company Name:
Medtronic
Job Location:
Mounds View, MN US
Job Category:
Healthcare & Medical
Prin Clinical Research Spec Job
Prin Clinical Research Spec
Requisition 73461 Category Clinical Studies Business Cardiac Rhythm Disease Mgmt Division CRDM AF Solutions Location USA-MN-Mpls-Mounds View Relocation Relocation eligibility to be determined Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage 10 - 20% Experience Required 5 years Education Required Bachelors Degree
Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description
The Principal Clinical Research Specialist will oversee designing, planning, development and monitoring of clinical research projects. Coordinates activities of associates and investigators to ensure compliance with protocol and research projects. Coordinates activities of associates and investigators to ensure compliance with protocol and all clinical objectives. Includes interfacing with representatives from key functional groups including Field Clinical Engineering, Product Development, Manufacturing, Sales, Marketing, Distribution, and Regulatory Affairs.
Position Responsibilities
Determines study objectives, strategy, scope and schedule in order to meet business needs. Develops the Investigational Plan in consultation with the cross-functional project team, investigators and the clinical team. Selects, interfaces with, and assures training of investigators, center staff and Medtronic clinical staff. Interfaces with regulatory agencies including pre-IDE meetings with the FDA and presentations to FDA panel reviewers regarding requirements and results of the study. Ensures adequate monitoring is conducted on all clinical trials. Enlists support and specifies tasks for various clinical team members to assure meeting study objectives on schedule. Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and advice on direction. Provides input and support for planning post-clinical activities and market launch of products. Authors/co-authors results of studies in the medical literature and/or presents at scientific meetings. Develops and manages budgets for assigned studies. Controls device distribution and allocation. Provide work direction and leadership to the study team. Frequent organizational and outside customer controls. Represent the organization to provide solutions to difficult technical issues associated with specific projects.
Basic Qualifications
EDUCATION REQUIRED Bachelor's degree with 7 plus years experience or MA degree with 5 plus years experience.
YEARS OF EXPERIENCE Experience directly supporting clinical research, clinical, biological or other scientific lab.
Desired/Preferred Qualifications
MA, MBA or PhD Experience leading complex projects and project teams. Good negotiation and problem resolution skills. Expertise with GCPs and regulatory compliance guidelines for clinical trials. Research experience. Experience with sales. Experience with FCE personnel or has performed the FCE role. Entrepreneurial mindset. Comfortable with ambiguity. Knowledge of clinical and outcomes research study design. High attention to detail and accuracy. Advanced written and oral communication skills. Able and willing to manage multiple tasks at all levels. Proficient knowledge of medical terminology. FDA experience. Independent self-starter.
Physical Job Requirements
The physical demands described here 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. Must be able to sit/stand/walk 8 hours per day. Ability to freely move throughout the facility, use a phone, keyboard and mouse, visually able to interact with personal computers. Able to lift 20 pounds Ability to travel at least 20%.
