eTMF Specialist

4 weeks ago

Chicago, United States Cardiosense Inc. Full time

Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.About the role:The eTMF Specialist is responsible for leading the design and set-up of the Cardiosense electronic Trial Master File (eTMF) system. This role is a contract position, estimated for between 3-6 months .What youll be doing: Lead, design, build and develop Trial Master File structure per applicable regulatory guidanceBuild and develop study specific eTMFs with appropriate security permissionsDevelop and refine eTMF workflow/tactical executionPopulate eTMFs with required essential documentsAuthor/co-author required content and training for eTMF as neededDevelop and execute plan for superseded documents in eTMFSupport eTMF related tasks as directedManage daily tasks and refine electronic data captures (EDCs) based on business and study needsQualifications: Bachelors degree in science or relevant experience in healthtech/clinical research5+ years of relevant FDA documentation experiencePrevious experience working with and building eTMFs requiredStrong knowledge of eTMF structure, content, essential documents, naming conventions and documentation management requiredSolid understanding of ICH-GCP guidelines and regulatory requirements related to clinical document management/eTMFsPreferred: Experience with cardiac domain specific clinical trialsExperience routing through AoDocsExperience with EDCsCardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.#J-18808-Ljbffr

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