[Remote] Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. The Clinical Study Manager (CSM) is responsible for the planning, execution, and oversight of clinical investigations for medical devices, ensuring compliance with regulatory requirements and collaborating with cross-functional partners to generate high-quality clinical evidence.ResponsibilitiesLead the planning, design, and execution of clinical studies (IDE, post-market, PMCF, registries, and observational studies) in alignment with business and regulatory strategyManages and oversee all aspects of clinical research projectsEnsure projects are timely, are evaluating accurate data, and are producing precise resultsPlans, directs, creates, and communicates the study timelineDevelops detailed project plans, and monitors project milestones against performance indicatorsEnsures the project is planned and conducted in accordance with all applicable regulations, standard operating procedures, and good clinical practices (GCP)Manages risk assessment and mitigationGenerates reports to provide periodic status updatesDevelop, review, and manage clinical study documentation, including protocols, informed consent forms, case report forms (CRFs), statistical plans (as applicable), and clinical trial agreementsServe as the primary operational lead for assigned studies from site selection through study closeoutCoordinate site feasibility, selection, qualification, initiation, monitoring, and close‑out activitiesProvide oversight of site performance, enrollment, data quality, and protocol complianceSupport training and ongoing communication with investigators and site staffEnsure clinical investigations are conducted in accordance with ISO 14155, FDA regulations, EU MDR, and applicable international GCP requirementsSupport regulatory submissions, audits, and inspections by maintaining inspection‑ready Trial Master Files (TMF) and related clinical documentationCollaborate with Regulatory Affairs to ensure alignment between study design, clinical evidence generation, and regulatory strategyManage and oversee clinical research organizations (CROs), laboratories, and other vendors to ensure delivery of contracted servicesDevelop and manage study budgets, forecasts, and resource plans; monitor expenditures against approved budgetsIdentify and mitigate operational, timeline, and budgetary risksTrack study milestones, timelines, and deliverables using clinical trial management toolsMonitor data quality and completeness; coordinate resolution of data queries and issuesEnsure accurate, timely reporting of study status, risks, and results to internal stakeholdersProvide guidance, training, and operational oversight to Clinical Research Associates (CRAs) and other study team members, as applicableContribute to continuous improvement of clinical operations processes, procedures, and best practicesSkillsBachelor's degree in Life Sciences, Engineering, or a related field required3–8+ years of experience in clinical research, with a minimum of 2+ years in medical device study managementDemonstrated experience managing pre-market and/or post-market medical device clinical studiesHands-on experience with site start-up, enrollment management, monitoring oversight, and CRO managementStrong knowledge of ISO 14155, FDA regulations, EU MDR, and GCPProficiency with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF)Working knowledge of medical device quality systems and clinical documentation requirementsStrong project management, organizational, and risk‑management skillsExcellent written and verbal communication skillsAbility to work effectively in a fast-paced, cross-functional environmentDemonstrated leadership and problem‑solving capabilitiesMaster's degree or PhD preferredCertification through a professional organization such as ACRP or SOCRAExperience working with interventional or procedural studies (IR, vascular, cardiology preferred)Company OverviewArgon Medical is a global manufacturer of specialty medical products, headquartered in Plano, TX. It was founded in 2003, and is headquartered in Plano, Texas, USA, with a workforce of 1001-5000 employees. Its website is http://www.argonmedical.com/.Company H1B SponsorshipArgon Medical Devices, Inc. has a track record of offering H1B sponsorships, with 1 in 2026, 16 in 2025, 13 in 2024, 6 in 2023, 7 in 2022, 3 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.