Clinical Research Scientist

Clinical Research ScientistAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.This position works out of our Plymouth, MN location, in the Electrophysiology division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.The Clinical Research Scientist will participate in scientific and operational activities supporting the design, conduct, analysis, interpretation, and reporting of clinical studies within Abbott's Electrophysiology portfolio. This role contributes to the generation of clinical evidence supporting product development, regulatory approvals, reimbursement initiatives, post-market surveillance activities, and scientific communication efforts.The Clinical Research Scientist will work collaboratively across multiple functions to support clinical research programs from study planning through publication and reporting while developing expertise in clinical research methodology, medical device development, scientific communication, and evidence generation.This position will work closely with the clinical study team including clinical scientists, project management, clinical operations, biostatistics, data management, regulatory affairs, quality affairs, medical affairs, reimbursement, and research and development personnel. This position will execute limited scoped responsibilities in accordance with applicable regulations, company procedures, and quality system requirements. Additionally:Contribute to the development, review, and maintenance of study-related documents including clinical study protocols, protocol amendments, case report forms, investigator brochures, informed consent forms, study manuals, clinical study reports, and associated scientific documentation.Support the planning, execution, analysis, and reporting of prospective clinical studies, registries, observational studies, post-market studies, and other evidence-generation activities.Conduct literature reviews, scientific assessments, competitive analyses, and evidence evaluations to support protocol development, endpoint selection, publication activities, clinical strategy discussions, and evidence-generation planning.Collaborate with clinical operations and CRO partners to support study execution activities, enrollment monitoring, site communications, protocol compliance activities, issue identification, and study-risk mitigation efforts.Review clinical data listings, summary tables, statistical outputs, and study reports and contribute to interpretation of study outcomes, safety findings, and clinical evidence.Participate in scientific data reviews and contribute to analyses supporting study conclusions, publication activities, clinical evaluation activities, and evidence-generation initiatives.Contribute to development of scientific manuscripts, abstracts, posters, white papers, podium presentations, and other scientific communications intended for internal and external audiences.Support publication activities through scientific writing, literature reviews, data review, and collaboration with internal teams and external authors.Contribute to compilation and organization of clinical evidence supporting regulatory submissions, clinical evaluations, reimbursement activities, and regulatory authority responses.Support maintenance of clinical study documentation, inspection readiness activities, audit activities, and compliance with quality system requirements.Participate as an active member of study teams and contribute scientific input during protocol development, study execution, data analysis, and reporting activities.Communicate scientific findings, study progress, and project updates to department stakeholders.Develop working knowledge of electrophysiology therapies, cardiovascular disease states, product technologies, clinical evidence, and evolving treatment paradigms.Build collaborative working relationships with investigators, research coordinators, study sites, and cross-functional business partners.The job will be performed in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Required Qualifications:Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.Minimum experience equivalency: BS + 2-4 years relevant experience, MS + 0-2 years relevant experience, PhD + 0 years relevant experience.Demonstrated scientific writing ability.Foundational understanding of clinical research methodology, clinical trial design, and evidence generation.Ability to critically evaluate scientific literature and apply findings to scientific and clinical research questions.Foundational understanding of statistical concepts including study endpoints, hypothesis testing, confidence intervals, and interpretation of clinical study results.Effective written and verbal communication skills with the ability to communicate scientific information to cross-functional stakeholders.Working knowledge of Good Clinical Practice and clinical research regulations.Ability to work effectively within multidisciplinary project teams.Strong organizational skills with the ability to manage multiple priorities and deadlines.Broad knowledge and application of business concepts, procedures, and practices.Preferred Qualifications:Advanced degree preferred.Medical device clinical research experience.Knowledge of electrophysiology therapies and cardiovascular clinical research.Experience supporting clinical trials or investigator-sponsored research.Working knowledge of clinical trial statistics including endpoints, confidence intervals, p-values, and hypothesis testing.Familiarity with FDA, MDR, ISO 14155, HIPAA, and GDPR requirements.Experience authoring or contributing to scientific manuscripts, abstracts, posters, or presentations.The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.