Heart Rhythm Clinical Research Solutions

Role Description The Sr. Clinical Research Manager is responsible for leading teams to execute on all aspects of clinical trial management across the study life cycle from planning to execution to closure. They work with cross-functional partners to implement process improvements, execute high-quality evidence, and drive our strategic partnership with clients and customers. They also leverage project management expertise to guide projects under their direct leadership. - Develop strong customer and client relationships ensuring appropriate expectations are met and exceeded. - Help develop talent, set goals, align on expectations and drive accountability with direct reports as well as identify future strategic direction across clinical operations portfolio. - Maintain up-to-date knowledge of regulatory requirements related to study management. - Track and follow-through on process improvement projects as well as studies we are supporting. - Determine study objective, strategy, scope and schedule to meet business needs. - Able to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget. - Able to see multiple viewpoints and build consensus to reach resolutions. - Support the development of the Clinical Investigational Plan and supporting documents (ICF, Monitoring Plan, Data Management Plan, etc.) in consultation with the cross-functional project teams. - May provide clinical training of investigators, center staff, and internal team members. - May evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study execution. - May participate in the selection and management of CRO vendors and contractors. - May provide oversight/review of monitoring reports, CTMS/eTMF process implementation, and lead special projects for the portfolio. - Develop a high level of professional scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/outside experts or departments/institutes. - May develop and manage budgets for assigned clinical research projects. - Prepare outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership. - Follow and help iterate Clinical SOPs, systems and processes ensuring quality study management. - Perform other duties as assigned. Qualifications - Bachelor’s degree in a life science or related field. - A combination of experience and/or education will be taken into consideration. - Minimum of 8 years of experience within a Contract Research Organization (CRO), biotech, or pharmaceutical company with significant clinical research experience. - Minimum 2 years of people management experience. - Knowledge of GCP, FDA, and other regulatory requirements related to trial management. - Strong attention to detail and organizational skills. - Good communication, interpersonal skills, and talent management skills. - Healthy disdain for the status quo. - Ability to thrive in a fast-paced and dynamic early-stage company work environment. Requirements - This is a remote position and may be performed anywhere within the United States of America. - Regular domestic travel will be required for site visits, company meetings, audits, etc. Company Description

Role Description The Senior Project Manager is a key role responsible for successfully planning, coordinating, overseeing, and executing clinical trials and registries in alignment with HRCRS standards and the Client’s/Financial Entity’s requirements. They serve as the primary liaison for all project-related communications, ensuring that studies are progressing according to plan and that all stakeholders are both informed and engaged. This role requires strong leadership, strategic planning, and operational oversight to ensure the successful execution of global clinical trials/registries while maintaining compliance with regulatory standards. The Senior Project Manager provides strategic leadership, including portfolio planning, client/financial entity engagement, as well as high-level risk mitigation. What you'll do - End-to-end project management from study start-up to closure including ensuring that all relevant project plans are implemented as applicable (eTMF, Monitoring, & Data Management Plans, etc). - Strategizes portfolio planning and ideas to support Client engagement. - Acts as the strategic liaison with Client/Financial Entity, provides guidance on trial/registry direction, innovations, and long-term planning. - Oversees planning, execution, and completion of cardiac-focused medical device clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements. - Ensures applicable study training is assigned to project team members in collaboration with Quality. - Develops project plans, risk management strategies, and contingency plans to address potential trial challenges. - Ensures the accuracy and integrity of clinical trial data. - Act as the primary point of contact for Clients/Financial Entities, providing project updates, strategic guidance, and risk mitigation strategies. - Lead cross-functional teams that include clinical operations, data management, biostatistics, regulatory affairs, and quality assurance. - Provides oversight of direct reports including conducting performance reviews/support goal setting. - Demonstrates accountability by completing all mandatory training on time and in accordance with company requirements. - Regular and reliable attendance. - Other duties as assigned. Qualifications - Bachelor’s degree in Life Sciences or related field. PMP, master’s degree, or relevant certification is preferred. However, a combination of experience and/or education will be taken into consideration. - Minimum of 8 years of experience in clinical project management within a Contract Research Organization (CRO), biotech, medical device, or pharmaceutical company. - In-depth understanding of clinical trials, including planning, execution, and regulatory requirements. - Strong knowledge of ISO 14155, ICH-GCP, FDA IDE trials, and global medical device regulations. - Strong project management skills, with the ability to manage multiple projects simultaneously. - Proven ability to manage multiple complex clinical studies simultaneously. - Excellent communication, negotiation, and leadership skills. - Experience with clinical trial management systems (CTMS), electronic data capture (EDC), and risk-based monitoring approaches. Requirements - This is a fully remote position and may be performed anywhere within the United States of America. - Occasional domestic and international travel may be required for company meetings, site visits, audits, etc. Company Description This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

About the role The Project Manager is a critical role responsible for planning, coordinating, overseeing, and executing the clinical trials in alignment with the organization's standards and the sponsor's requirements. They serve as the primary liaison for all project-related communications, ensuring that trials are progressing according to plan and that all stakeholders are informed and engaged. What you'll do - Plan, coordinate, and oversee all stages of clinical trials, including project planning, budgeting, resource allocation, execution, and closeout. - Ensure that clinical trials are conducted in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and applicable regulatory requirements. - Serve as the primary contact for sponsors, investigators, and other stakeholders, providing timely and accurate project updates. - Identify project risks and develop and implement mitigation strategies. - Collaborate with internal teams and external vendors to ensure that project goals are met. - Oversee data management activities, ensuring the accuracy and integrity of clinical trial data. - Conduct regular project meetings, documenting and following up on important actions and decisions. - Prepare and present project reports to senior management and stakeholders. - Demonstrates accountability by completing all mandatory training on time and in accordance with company requirements. Qualifications - Bachelor’s degree in a life science or related field. A master’s degree or relevant certification is preferred. However, a combination of experience and/or education will be taken into consideration. - Minimum of 5 years of experience in clinical project management within a Contract Research Organization (CRO), biotech, or pharmaceutical company. - In-depth understanding of clinical trials, including planning, execution, and regulatory requirements. - Strong project management skills, with the ability to manage multiple projects simultaneously. - Excellent communication and interpersonal skills. - Strong problem-solving skills and the ability to adapt to changing circumstances. - Proficiency in project management software and other relevant tools. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

About the role The Clinical Scientist supports the design, execution, analysis, and dissemination of real-world evidence and implementation research studies. This role sits at the intersection of clinical research, implementation science, and collaborative medical writing. This role brings a passion for translating scientific insights into clinical and procedural advancement through rigorous methods and cross-functional teamwork. The Clinical Scientist contributes to investigator-initiated and sponsor-supported research projects, with a strong focus on registry-based studies, healthcare technology evaluation, and workflow optimization across diverse healthcare settings. This is a core team member in research protocol development, data interpretation, stakeholder engagement, and scientific dissemination. What you'll do Scientific Writing & Dissemination - Lead & support development of scientific manuscripts, white papers, & reports based on HRCRS registry data and partner-sponsored studies - Draft abstracts, posters, and oral presentations for national and international scientific meetings - Translate technical findings into usable outputs for sponsors, investigators, and health system leaders Collaborative and Team Science - Contribute to multi-stakeholder research initiatives, including coordination with clinicians, statisticians, project managers, and device sponsors - Facilitate and synthesize outputs from collaborative workshops, clinical roundtables, and working groups - Support and co-lead implementation planning sessions with external research and clinical teams Clinical & Implementation Research Support - Assist with protocol development, study design, and implementation strategies for real-world studies - Apply implementation science frameworks to analyze procedural workflows, clinical adoption, and stakeholder feedback - Generate synthesis reports and decision memos to inform product launches or technology deployment strategies Data Interpretation & Stakeholder Communication - Review and interpret results from statistical analyses in collaboration with data teams - Conduct qualitative or mixed-methods synthesis of clinician interviews or surveys - Communicate findings clearly to internal and external stakeholders for actionability and uptake Quality Improvement and Innovation - Contribute to internal initiatives to improve scientific deliverables, project workflows, and knowledge translation - Stay current on trends in implementation research, registry science, and medical device evaluation Qualifications - PhD, DrPH, ScD, MD, PharmD, or equivalent terminal degree in Public Health, Epidemiology, Health Services Research, Implementation Science, or a clinical field - 3+ years of experience in outcomes research, implementation research, health services research, or medical device evaluation (industry or academic setting) - Demonstrated expertise in writing and publishing scientific manuscripts, abstracts, and regulatory submissions - Experience collaborating with multidisciplinary research teams, including clinicians, statisticians, and project managers Key Skills & Competencies - Exceptional scientific writing and communication skills for both technical and non-technical audiences - Understanding of real-world evidence generation, including use of registry and observational data - Familiarity with implementation science frameworks (e.g., CFIR, RE-AIM) and dissemination strategies - Proficiency in collaborative platforms and team science tools (e.g., Google Workspace, MS Teams, version control tools, project tracking software) - Ability to translate complex data and stakeholder feedback into clear recommendations and reports - Flexible, detail-oriented, and comfortable working in fast-paced, high-accountability environments LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

About the role The Associate Internal Clinical Research Associate (iCRA) is responsible for supporting and coordinating clinical study activities in accordance with applicable regulatory guidelines, sponsor requirements, and organizational standard operating procedures. The Associate iCRA plays a key supporting role to Clinical Study Managers (CSM) by assisting with overall study management and maintaining the study electronic Trial Master File (eTMF). The Associate iCRA plays a critical role in the project lifecycle of study start-up through close-out. The Associate iCRA ensures all activities are conducted in accordance with International Council for Harmonization Good Clinical Practice (ICH- GCP), and all other applicable regulatory requirements and guidelines. What you'll do - Assist with the management of study mailboxes, ensuring timely responses where needed and appropriate filing into the eTMF. - Support preparation of protocols, case report forms, IRB/EC submissions / documents. - Assist with site qualification and site initiation visits in collaboration with clinical operation teams. - Support study start-up activities including but not limited to collection, review and tracking of essential documents. - Work directly with sites to ensure all requirements are met prior to sites being activated. - Assist with maintenance and the development of study trackers (site contacts, FAQ log, training, payment reconciliation, etc.) - Assist with the preparation of project communications, such as newsletters and team presentations, to update stakeholders on study progress and operational status. - Maintain the eTMF for assigned studies and ensure that they are audit ready. - Assist with the study close-out process on a site level and study level. - Work closely with Clinical Study Manager, Monitors, study teams, clients, and sponsor representatives to ensure seamless study execution. - Assist with internal team meetings as required. - Participate in process improvement initiatives, SOP updates and functional working groups. - Participate in the development of tools and templates that benefit the broader iCRA team. - Assist with audits and inspections. - Perform other duties as assigned. Qualifications - Bachelor’s degree in life science, data science, or related field. However, a combination of experience and/or education will be taken into consideration. - Minimum of 2 years of experience in clinical research. - Understanding of GCP, FDA, ICH, and other regulatory requirements related to Clinical Research - Excellent attention to detail and problem-solving skills. - Good communication and interpersonal skills. - Healthy disdain for the status quo. - Proficiency in data monitoring software and other relevant tools such as EDC. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Cloud Engineer is responsible for designing, implementing, and managing the organization’s Microsoft Azure cloud infrastructure. This role ensures the cloud environment is secure, scalable, and efficient by applying Azure best practices, automation, and security standards, while supporting business and technology objectives through reliable and well-architected cloud solutions. - Design & Deployment: Architect, deploy, and manage Azure-based cloud infrastructure solutions to meet business and technical requirements. - Infrastructure as Code: Implement automation using tools such as ARM Templates, Bicep, Terraform, or Azure CLI. - Monitoring & Optimization: Monitor performance, availability, and costs of Azure resources; implement cost-saving strategies. - Security & Compliance: Configure Azure security tools (Defender for Cloud) and policies, ensure compliance with industry standards (e.g., SOC, GDPR). - Troubleshooting: Diagnose and resolve issues related to cloud systems, networking, and integrations. - Collaboration: Work closely with development, DevOps, and cybersecurity teams to support application deployment and cloud strategy. - Documentation: Maintain accurate documentation for architecture, configurations, and operational processes. - Demonstrates accountability by completing all mandatory training on time and in accordance with company requirements. - Regular and reliable attendance. - Other duties as assigned. Qualifications - Bachelor’s degree in Computer Science, Information Technology, or related field (or equivalent experience). - 3+ years of hands-on experience with Microsoft Azure. - Familiarity with the Microsoft Cloud Adoption Framework. - Proficiency in Azure services such as Azure Virtual Machines, Azure Functions, Azure Storage, Azure Networking, Azure Kubernetes Service (AKS), and Azure Active Directory. - Strong scripting and automation skills (PowerShell, Bash, Python). - Experience with CI/CD pipelines using Azure DevOps. - Understanding of cloud security principles and identity management. - Familiarity with monitoring tools (Azure Monitor, Log Analytics). Requirements - Microsoft Certified: Azure Administrator Associate or Azure Solutions Architect Expert (preferred). - Familiarity with cost management and governance in Azure (preferred). Benefits - This is a fully remote position and may be performed anywhere within the United States of America. - Occasional domestic and international travel may be required for company meetings, audits, etc.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Data Systems Associate is an early‑career, hybrid clinical–technical role designed for individuals who can bridge clinical data workflows with technology, systems thinking, and hands‑on software validation. This position supports the development, maintenance, and continuous improvement of our proprietary Electronic Data Capture (EDC) platform, used across medical device clinical trials. Success in this role requires someone who brings foundational clinical research experience, an aptitude for database and system logic, and the curiosity and adaptability to partner across Data Management and Software Development. This is not an entry-level role, but rather a growth-oriented opportunity for candidates who have established a foothold in clinical data or clinical technology and want to deepen both. What you'll do - System Support & Troubleshooting - Identify, document, and triage system issues or user‑reported bugs in the in‑house EDC platform. - Support the implementation and verification of fixes and enhancements with Software Development. - Perform initial root‑cause analysis for Azure‑based issues before escalating. - Clinical Data Workflow Support - Translate Data Management needs into actionable tickets, requirements, or feature requests. - Support form testing, CRF logic verification, and data query workflows. - Assist data managers in day‑to‑day use of the system to ensure accuracy and efficiency. - Documentation & Testing - Create and execute test scripts as part of system validation and release cycles. - Maintain accurate system documentation, user guides, and training resources. - Log issues, enhancements, and validation activities in alignment with QA processes. - Cross‑Functional Collaboration - Participate in regular Software–DM syncs to stay aligned on priorities and release plans. - Deliver user training and frontline support for clinical study teams. - Serve as a liaison between operational users and the technical team. Qualifications - Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. Requirements - 1–3 years in clinical data management, clinical systems support, clinical research technology, or software QA within a clinical research environment. - Exposure to EDC platforms (REDCap, Medidata, OpenClinica, or homegrown). - Familiarity with Microsoft Azure tools (Azure SQL, Azure DevOps, Functions). - Understanding of FDA 21 CFR Part 11, ICH‑GCP, and clinical data documentation standards. - Basic understanding of relational databases and structured data (SQL a plus). - Strong communication, documentation discipline, and cross‑team collaboration abilities. - High attention to detail and strong organization in a fast‑moving environment. - Ability to perform User Acceptance Testing (UAT) to ensure new features and fixes meet intended requirements. Preferred Qualifications - Prior experience with software testing, QA processes, or system validation. - Experience collaborating with both technical and clinical teams. - Experience with clinical workflow analysis or system optimization work. Location and Travel Requirements This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc.

About the role The Program Coordinator – Scientific Affairs supports the planning, coordination, and execution of HRCRS scientific initiatives, serving as a central operational and research support role within the Scientific Affairs department. This position blends project coordination, research assistance, and scientific operations, enabling the successful delivery of registry-based research, survey research projects, investigator collaborations, and sponsor-supported studies. The Program Coordinator works closely with scientists, statisticians, project managers, and external collaborators to ensure that scientific projects remain organized, methodologically sound, and on schedule. This role is ideal for an individual with formal training or applied experience in research who is seeking to build depth in real-world evidence generation, implementation research, and healthcare technology evaluation. What you'll do Scientific Project Coordination - Coordinate timelines, milestones, and deliverables for Scientific Affairs projects, including registry studies, survey research initiatives, and collaborative research programs - Track project status, action items, and dependencies to ensure timely execution and follow-through - Support meeting preparation, documentation, and follow-up for scientific working groups, investigator meetings, and research workshops Research Support & Assistantship - Assist with research protocol development, study documentation, and regulatory or ethics-related materials as needed - Support data-related activities, including data cleaning support, literature reviews, qualitative transcript organization, or synthesis preparation - Assist in the preparation of scientific outputs such as abstracts, posters, reports, and internal research summaries - Maintain organized study files and documentation in accordance with HRCRS research standards Cross-Functional Collaboration - Serve as a liaison between Scientific Affairs and internal teams such as Operations and RWE. - Coordinate with external stakeholders, including clinicians, investigators, research sites, and industry partners - Support collaborative research activities by organizing inputs, tracking feedback, and synthesizing outputs Documentation, Tracking & Reporting - Maintain accurate project documentation, trackers, and reporting tools to support transparency and accountability - Prepare internal status updates and summary materials for Scientific Affairs team Quality, Growth & Innovation - Contribute to continuous improvement of Scientific Affairs workflows, templates, and project management practices - Stay current with developments in clinical research, public health research, and implementation science - Support special projects and emerging initiatives within the Scientific Affairs department as assigned Qualifications Education & Experience - Bachelor’s or Master’s degree in a scientific field such as Public Health, Health Sciences, Epidemiology, Biology, Social Sciences, or a related discipline OR A combination of relevant education and substantial experience in clinical, public health, or health services research - Prior experience or formal training in research methods (quantitative, qualitative, or mixed methods) - Experience in a research, academic, healthcare, CRO, or public health setting preferred Core Skills & Competencies - Strong organizational and project coordination skills, with the ability to manage multiple workstreams simultaneously - Working knowledge of research workflows, including protocol development, data collection, IRB-related processes, or study documentation - Excellent written and verbal communication skills, particularly for scientific and professional audiences - High attention to detail and commitment to accuracy in documentation and reporting - Proficiency with collaborative tools and project tracking platforms (e.g., MS Teams, MS Excel, HubSpot) - Ability to work independently while contributing effectively to cross-functional scientific teams - Interest in real-world evidence, implementation science, healthcare innovation, or medical technology evaluation LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

About the role The Marketing and Brand Manager will be responsible for shaping, implementing, and managing the marketing and brand strategies for both HRCRS and 3PH Alliance. This role requires a creative and strategic thinker who can balance storytelling with data-driven insights. You’ll lead initiatives that elevate our visibility, strengthen brand identity, and drive engagement across digital, print, and event platforms. What you'll do KEY RESPONSIBILITIES: - Brand Strategy & Development - - Develop and maintain a cohesive brand strategy for HRCRS and 3PH Alliance that aligns - with organizational goals. - Ensure brand consistency across all internal and external communications. - Create and manage brand assets, tone, and messaging guidelines. - Marketing Campaign Management - - Design, execute, and analyze integrated marketing campaigns (digital, social media, email, and print). - Collaborate with leadership to identify target audiences and growth opportunities. - Measure and report performance metrics, optimizing campaigns for engagement and ROI. - Content Creation & Communication - - Oversee development of high-quality marketing materials including newsletters, brochures, case studies, and presentations. - Manage content for company websites and social media channels. - Craft compelling narratives that position both organizations as leaders in healthcare innovation and collaboration. - Partnership & Event Support - - Support the planning and promotion of conferences, webinars, and strategic partnership events. - Collaborate with internal teams to develop marketing collateral for key initiatives and partnerships. - Market Research & Insights - - Monitor industry trends, competitor activities, and emerging digital strategies. - Provide actionable insights to guide leadership decisions and strategic positioning. Qualifications - Bachelor’s degree in Marketing, Communications, Business, or a related field - 5+ years of experience in marketing, brand management, or communications—preferably in healthcare, research, or professional services. - Strong understanding of digital marketing tools (SEO, analytics, email automation, CRM, etc.). - Excellent written, visual, and verbal communication skills. - Experience managing multiple brand identities or partnerships is a plus. - Creative mindset with an ability to blend strategy, design, and storytelling. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

About the role We are seeking an experienced Sr. Clinical Data Manager to lead and oversee data management activities for medical device clinical trials, with a focus on Electrophysiology (EP). This role involves ensuring high-quality, regulatory-compliant data collection and analysis to support clinical trials from start-up to submission. The ideal candidate will have expertise in clinical data management, regulatory compliance, and database development, with a strong understanding of clinical trial processes in the medical device industry. Experience in Electrophysiology (EP) trials is a plus but not mandatory. What you'll do Clinical Data Management & Oversight - Lead all aspects of data management for medical device clinical trials, ensuring compliance with FDA, MDR, ICH-GCP, and ISO 14155 regulations. - Develop and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs) aligned with study protocols. - Design, validate, and manage Electronic Data Capture (EDC) systems such as Medidata RAVE, Oracle InForm, or Veeva Vault EDC. - Oversee data cleaning, query management, and reconciliation processes to ensure high-quality, analyzable datasets. - Ensure adherence to CDISC/CDASH/SDTM standards, enabling efficient regulatory submission. - Conduct and support data audits, quality control (QC) reviews, and database lock activities. Project & Team Leadership - Serve as the data management lead for multiple studies, collaborating with cross-functional teams including clinical operations, biostatistics, and regulatory affairs. - Work closely with electrophysiology (EP) experts, principal investigators, and clinical research teams to ensure accurate data collection and interpretation. - Provide mentorship and guidance to junior data managers and other team members. - Manage relationships with CROs, vendors, and external data management teams, ensuring alignment with project timelines and quality standards. Regulatory Compliance & Quality Assurance - Ensure compliance with FDA 21 CFR Part 11, ICH-GCP, ISO 14155 (for medical devices), and MDR regulations. - Support regulatory submissions (e.g., PMA, 510(k), CE Mark, IDE) by ensuring proper data documentation and formatting. - Participate in audits and inspections by regulatory bodies and implement corrective actions as needed. - Stay updated on evolving medical device data management best practices and regulatory requirements. Data Reporting & Analysis - Generate and review clinical study reports, data listings, and reconciliation outputs. - Support statistical programming and data analysis in collaboration with biostatistics teams. · Ensure seamless data integration with clinical trial management systems (CTMS) and safety databases. Qualifications Education & Certifications - Bachelor's or Master's degree in Life Sciences, Clinical Research, Biostatistics, Computer Science, or a related field. - Certified Clinical Data Manager (CCDM) or equivalent certification is a plus. Experience - 5+ years of experience in clinical data management within the medical device industry or related healthcare sectors. - Proven experience in Phase I-IV clinical trials, IDE/PMA/510(k) submissions, or post-market studies. - Strong knowledge of electrophysiology (EP) trials is a plus but not required. - Experience managing EDC systems (e.g., Medidata RAVE, Veeva Vault, Oracle InForm, Medrio). - Familiarity with ISO 14155, CDISC/CDASH/SDTM, and FDA 21 CFR Part 11 compliance. - Knowledge of SQL, SAS, or other clinical data programming tools is beneficial. Skills & Competencies - Strong leadership, problem-solving, and analytical abilities. - Excellent attention to detail and ability to manage multiple clinical studies simultaneously. - Strong communication and collaboration skills for working with clinical, regulatory, and biostatistics teams. - Ability to work effectively with CROs, vendors, and external stakeholders. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.