The Sr Principal Clinical Research Specialist/Scientific Literature Reviewer is responsible for reviewing literature, medical evidence tracking, publication planning, reviewing marketing materials, and evaluation and execution of physician sponsored studies. The position is also responsible for developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and global nature. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met.
• Follow all work/quality procedures to ensure quality system compliance and high quality work.
• Conduct and document reviews of scientific literature in collaboration with marketing, regulatory affairs and quality organizations
• Provides project management and assures successful conduct of assigned projects. This includes leading the clinical team and/or being the clinical representative on the core team for therapy or product development and interfacing with representatives from key functional groups including Statistics, Clinical Quality, Reimbursement, Regulatory Affairs, Marketing, Medical Education, Legal, and International Clinical. Research Groups, and Product Development (as needed).
• Prepare accurate and timely reports to Regulatory Affairs.
• May develop the required clinical/project documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan, CERs) in consultation with the cross-functional team, investigators, and the core clinical team.
• Ensures activities are in line with milestones and implement contingency plans as needed.
• Work with investigators to quickly and effectively resolve problems.
• Evaluates clinical data/information and prepares interim and final reports.
• May provide input and support for launch, education, and marketing of products.
• May author/co-author results of studies in the medical literature.
• May develop study budget and manage study spending to plan.
• May interview and participate in hiring decisions for clinical personnel.
• May represent clinical on the therapy core team, depending on experience and technical expertise.
• Ensure adherence to FDA, Regulatory, and Medtronic requirements.
• Evaluate external research proposals for scientific soundness.
• May facilitate meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees.
• Execute current research proposals to approved deliverables
BS or BA with 10 years’ experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, and 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 8 years’ experience or PharmD, PhD, DVM, or MD with 5 years’ experience supporting clinical research
• Working knowledge and experience with the Medtronic SYNCHROMED II programmable pump.
• Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals.
• 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).
• 3 years in study management
• Experience working with Microsoft Word, Excel, PowerPoint and familiarity with web-based applications
• 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.
• Experience in assessing medical evidence
• Experience in publication planning
• At least three years of monitoring experience preferred
• 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 identify clinical evidence and strategies that are in alignment with defined business priorities and product planning strategies that optimally position products for approval and/or provide critical clinical evidence for existing products on the market.
• 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 up to 50%
ATS Medical, Inc.
Website : http://www.atsmedical.com