Careers that Change LivesWe are excited to be hiring aSr Clinical Quality Specialist?to join the?Medtronic Diabetes Operating Unit. ?In this role, you will be providing support to a Medtronic Diabetes clinical research study team.This position will beHYBRID at Northridge Facility.The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose?control, while spending less time managing their disease.? Join our diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.A Day in the Life?Responsibilities?may?include?the?following?and?other?duties?may?be?assigned. TheSr Clinical Quality Specialistsupports multiple activities for the conduct of clinical research studies, Operations and special projects in compliance with applicable regulatory standards, policies, procedures and department requirements.The Sr Clinical Quality Specialist is responsible for coordination of Clinical Quality Operations activities to assure compliance with regulations and Medtronic standards, guidelines and policies.Coordinate activities involving regulatory body inspections,internal and external audits, regulation and policy analysis and implementation, compliance and management review.Basic understanding of Good Clinical Practices (GCP) desired (e.g., clinical trial management systems, inspection and audit compliance management and reporting systems).This position works with minimal supervision in consort with the department and study managementExecute Clinical Operations Quality strategiesInspection coordination, documentation, tracking, trending, analysisAudit coordination, documentation, tracking, trending, analysisCAPA coordination,documentation, tracking, trending, analysisRegulation and policy review, gap analysis, implementation, trackingExecute Management review and reportingquality metric development, collection, analysis, trending, and trackingother management review function integration (e.g., supply chain)Advises on clinical quality assurance, review and prepare clinical study documentation for inspectionsConducts and performs investigations and ensures conformance to regulations and company standard operating procedures.Coordinate support for study teams to ensure successful audit and inspection activity consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conductDevelop Quality processes tocomply with applicable regulations, guidances and policiesProvide training on GCP and current regulations for those undertaking clinical studiesSupport risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.Attend and support clinical study meetings and Operations meetings (e.g., meeting facilitation, minutes, action item follow-up, arrangements, ad hoc assignments)Support development/revision and implementation ofprocedures aligned with relevant global regulations and standardsDetermine obstacles, identify solutions, and implement plans in collaboration with management to meet study objectives, scope and schedulesMust Have: Minimum RequirementsBachelor's degree and 4 years of work experience in clinical/clinical research within healthcare industry (i.e., medical device, biotech, pharmaceutical)or, Master's degree and 2 year of work experience in clinical / clinical research withinhealthcare industry (i.e. medical device, biotech, pharmaceutical)Experience with Quality-related projects/tasks (i.e. audit, reviews, clinical quality operations)Desired/ Preferred Qualifications:Experience in medical device clinical trials/clinical trial settingFamiliarity of Operations and Quality processesExperience in Project management and database systems (e.g., MS Project, Access, CTMS, SAP, Agile, Trackwise)Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel)Strong verbal and written communication skills, technical and problem solving skillsAble to read, analyze and interpret general business documents, technical procedures, and specificationsAble to write reports, business correspondence and procedure manuals effectivelyAble to work effectively, independently and on cross-functional teamsAble to frequently use general knowledge of industry regulations, practices, techniques, and standardsDevelops solutions to a variety of problems of moderate scope and complexityWilling to be flexible with work hoursAbout MedtronicTogether, 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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical 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. 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)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 handle and transport materials for shipments, interact with a computer, and communicate with peers and co-workers.EEO STATEMENT: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/employeesDISCLAIMER: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.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?here.This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) on page 6?here.The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc.
