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Responsibilities
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded wth, and impact.A Day in the LifeThe Senior Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements. This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. The Clinical Research Monitor may play a leadership role in managing monitoring activities.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 80% of travel to enhance collaboration and ensure successful completion of projects.Responsibilities may include the following and other duties may be assigned.Monitors progress of clinical trials at the site level and ensures that they are conducted, recorded and reported ndard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.Responsible for reviewing medical records with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.May assist with design, development, and monitoring of clinical evaluation projects.Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator complianceMay contact and recommend qualified investigators to perform studies and initiate clinical trials.Ensures recruitment and retention of patients.Mentor and/or train junior personnelAssist site/study teams with audit preparationAuthor Monitoring Plans and other study materialsEnsures monitors are trained, current with project requirements and understand study milestonesMust Have:Bachelor’s degree plus a minimum of 4 years of experience monitoring clinical trials (or advanced degree with 2+ years)Nice to Have:Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.Practical knowledge of project managementClinical experienceKnowledge of/experience with CTMS/EDC/eTMF/Veeva VaultExperience with Good Clinical Practice (GCP)Excellent interpersonal skillsExperience working in a team/matrix environment requiring strong working relationshipsAbility to handle and prioritize multiple therapeutic areas and projects simultaneouslyAbility to work in a fast-paced environmentCompetencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfactionDemonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.High attention to detail and accuracyExperience working independently in a regional area with remote or minimal supervisionStrong leadership skillsExcellent problem-solving skillsExperience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)Business knowledge or experience with the medical / healthcare industryClass III medical device and/or phase II, III and IV pharmaceutical experienceExperience to demonstrate understanding of technical, scientific and medical informationExperience with Regulatory and Quality Assurance auditsExperience of conducting clinical research activities in a regulated environmentProficient knowledge of medical terminologyRegulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Lat. as applicable)Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.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 position. Reasonable accommodations may be made to enable
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