Clinical Data Specialist

Company DescriptionIt started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.Job DescriptionPrimary Function of Position:The candidate will manage, maintain and support clinical treatment planning for multiple clinical studies/registries. The candidate will have an understanding of data review, oversight, and management systems. The candidate will be responsible for adhering to the required departmental operating procedures for clinical investigations. The candidate will have experience managing a variety of different data types, including EDC data and DICOM data, etc. Ideal candidates will have had operational experience managing clinical trial digital assets, as well as oversight and QC of the data. This role demands excellent organizational skills, attention to detail, and the ability to communicate effectively with stakeholders and medical staff.Roles and Responsibilities:Assess patient or subject medical histories, diagnostic findings, and clinical data to screen and identify eligible patients for ongoing studies, ensuring proper documentation of inclusion/exclusion criteriaCollaborate with physicians, clinical staff, and other stakeholders to facilitate the creation and revision of individualized treatment plans for patients or study subjects.Collect, record, and manage study data as required, ensuring accuracy, completeness.Track the execution of treatment plans, identify potential issues or deviations, and coordinate timely updates or adjustments as needed.Identify opportunities to streamline treatment planning processes and implement best practices for improved patient care or study outcomes.Management of outside vendor(s) providing digital imaging software solutions. Serve as the Sponsor main point of contact for all imaging data acquisition activities outsourced to external clinical vendors (i.e. CROs and Imaging Analysis Vendors).Serve as a point of contact between the clinical team, vendors, sponsor, and other involved parties regarding site activities and trial progress.Manage timelines and deliverables. Oversee outsourced activities including image upload, transfer and analysis imaging clinical trials.Lead regular cross functional meetings to review treatment planning data. Collaborate with stakeholders to identify key performance indicators (KPIs) for data quality and ensure they are met throughout the study. Provide clinical data management support for study operations and analysis groups including the following.Assist in creating of datasets and listings to correlate patient outcomes to treatment planning inputsData specifications and/or process data transfers in preparation for statistical review.Data cleaning and review of clinical data. Including query management and data listing review.Managing activities for multiple studies simultaneously in a dynamic environment.Contribute to development and/or maintenance of departmental operating procedures for data management.Proactive in understanding company needs/objectives and able to independently seek solutions. Works on significant and unique issues in critical situations and able to provide solutions proactively.QualificationsQualificationsSkill, Experience, Education, Training:Minimum BSc/BA in a scientific or medical fieldMinimum of 3-5 years of data management experience with a proven track record working on a medical device focused on COPD.3+ years experience with interventional pulmonology studies required.Experience with CT Imaging requiredExperience both adhering to set operating procedures and creating new procedures as new needs ariseExcellent Interpersonal skillsWork well in a team environmentWork independently to carry out tasks with minimal guidanceEffective written communication and interpersonal skills.Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.Desired to have experience with statistical software.Required to have medical knowledge as pertaining to medical devices for lung interventions.Expertise with the collection and review of medical images and procedure videos and radiology reports required.Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.Mandatory NoticesU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.Accommodation & Accessibility Notice:Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at View email address on click.appcast.io provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.SummaryType: Full-timeFunction: Public RelationsExperience level: AssociateIndustry: Medical Device