Prin Clinical Research Spec

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Prin Clinical Research Spec
Minneapolis, MinnesotaThe Principal Clinical Research Specialist is responsible for managing and meeting the objectives of clinical studies. This position will be responsible for managing a large post-market study and should be able to independently handle the most complex clinical study protocols and assignments and personnel management.
Responsibilities: Provides study management and assures successful conduct of assigned clinical programs consistent with R&D and Marketing plans and applicable regulations and policies. This includes interfacing with representatives from key functional groups including QC/ Clinical Engineering/Training, Biostatistics/Data Management, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs and Regulatory Compliance, and international Clinical Groups. Determines study objectives, strategy, scope and schedule to meet business needs. Develops the Investigational Plan in consultation with the cross-functional project team, investigators and the clinical team. Oversees the selection and management of Contract Research Orgnizations for assigned studies. Selects, interfaces with, and assures training of investigators, centers staff and Medtronic clinical staff. Interfaces with regulatory agencies including 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 advise 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. May provide supervision to clinical staff as required (i.e., personnel management expectation). Provides leadership in technical and/or clinical mentoring. Provides support in cost center management activities. Position requires up to 30% travel.
REQUIREMENTS
Requirements: Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. Maters degree will substitute for 1 year of experience. A PhD or MD will substitute for 2 years of experience. 8+ years experience directly supporting clinical research in a project team environment or similar experience in a medical/scientific area. 5-8 years experience directly managing clinical research studies and study teams. 1-year personnel management experience (one or more direct reports). Cost-center/budget experience. Experience with large, global post-marketing studies preferred.High attention to detail and accuracy. Advanced oral and written communication skills. Able to management multiple tasks. Proficient knowledge of medical terminology. Expertise with GCPs and regulatory and compliance guidelines for clinical trials. Good problem-solving skills. Significant knowledge of clinical and outcomes research study design. Demonstrated abiility to work effectively on cross-functional teams. Up to 30% travelWe are currently seeking multiple individuals for Clinical Studies opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Minneapolis, Minnesota. Other opportunities may also exist at our locations in Northridge, California; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.
TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Clinical Studies openings or enter Requisition # 50346 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.