Pulse Biosciences, Inc. logo

Pulse Biosciences, Inc.

Remote Jobs

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

7 open rolesTeam 51,200Since 2016H1B No SponsorLatest: Jul 8, 2026, 12:05 AM UTCCompany SiteLinkedIn
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7 Jobs

Pulse Biosciences, Inc. logo

Senior Clinical Trial Manager, Cardiac Catheter Products

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Work closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical trials for the 360 AF catheter ablation system. • Responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance. • Proactively identify, communicate and resolve clinical study operational issues. • Participate in process improvement initiatives. • Lead feasibility assessments, site selection, and activation for cardiology centers capable of handling complex AF trial requirements. • Proactively create and execute patient recruitment strategies and risk mitigation plans to meet study milestones. • Supervise Contract Research Organizations (CROs), core labs (e.g., ECG/Holter monitoring), and external vendors to ensure deliverables are met on time and within scope. • Assist in regulatory submissions to (CA, IRB/ECs) according to local requirements or e-submission through the Common European Submission Portal (CESP) in coordination with or without CRO. • Proactively track and manage project tasks against timelines by creating a Smartsheet or timely minutes to alert management when there are risks of having major deviations. • Draft and coordinate review of relevant documents including informed consents, source documents for data entry, power-point slide deck for site initiation visit, monitoring plans, clinical study and/or safety reports and study materials (e.g., newsletters, recruitment posters, study logs, etc.). • May assist in the preparation of documents required by Clinical Study Readiness. • May perform review and Quality Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF) as needed. • Oversee device tracking/accountability and reconciliation procedures at participating centers. • May conduct and/or attend SQVs, SIVs, IMVs and COVs and conduct site-level training, as needed. • Advise on site data collection and attend 360 AF catheter ablation clinical procedures as needed. • May perform User Acceptance Testing (UAT) in database for initial and ongoing eCRF development and contribute to the review of EDC guidelines. • Oversee the clinical aspects of timely data cleaning and data analysis by regular review of data metrics and listings. • Ensure that device or procedure related adverse events are identified and appropriate responses to such concerns are developed and executed as outlined in Safety Plan and/or Study Protocol. • Must have general functional expertise to support SOP development and implementation. • Evaluate vendor invoices for completeness and accuracy. • Hire, manage and develop internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.

United States
Pulse Biosciences, Inc. logo

Senior Clinical Research Associate, Cardiac Catheter Products

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Research Analyst79 days ago
Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Provide case support to research sites across multiple studies with minimal guidance. • Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries. • Coordinate review of data listings and preparation of interim and final clinical study reports. • Be responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data. • Be responsible for developing study specific monitoring tools and other related documents. • Deliver high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plans. • Ensure that all missing action items (MAIs) from monitoring visits are closed within the timelines of monitoring plans. • Be responsible for reviewing and approving essential regulatory documents across multiple studies. • Assist the project team in developing study metrics to ensure the efficient execution of a clinical trial. • Oversee clinical data to ensure queries are closed within stipulated timelines of study goals • Provide clinical support for submission of trials to IRB/IEC and regulatory authorities. • Ensure adherence to study timeline across multiple studies. • Coach and mentor other Clinical Research Associates (CRAs) in development and training. • Maintain strong working knowledge of protocols and product development across multiple studies. • Demonstrate ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team. • Demonstrate an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations. • Verify the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study. • Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. • Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies. • Manage Protocol Deviation documentation, tracking, and escalation. • Participate in site audits, as requested.

United States
Job Closed
Pulse Biosciences, Inc. logo

Senior Biostatistician

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies. • Plan methods to collect data and develop or review case report forms to ensure compatibility with plan design. • Evaluate reliability and validity of source information, apply weightings to raw data, and organize results in form appropriate to software requirements. • Designs clinical trials, analyzes study data to validate device safety and efficacy, and creates Statistical Analysis Plans (SAPs). • Perform advanced statistical analyses using appropriate methodologies. • Interpret results and provide strategic insights. • Review clinical literature and analyze Real-World Evidence (RWE) to set performance goals. • Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication target audiences. • Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries. • Performs analysis and generates visual/tabular data for scientific presentations and publications. • Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions.to ensure data integrity and accurate analyses. • Develop statistical tables and data summaries as needed. • Review project database structures, edit checks and data management coding conventions. • Ensure compliance with industry standards and guidelines. • May attend relevant scientific and/or medical meetings. • Support publication of study findings.

United States
Job Closed
Pulse Biosciences, Inc. logo

Medical Writer

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Medical writer81 days ago
Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Audit, edit, and maintain clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator’s Brochures (IBs), IFUs, Post-Market Clinical Follow-up (PMCF) plans and reports, and risk management documentation. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences SOPs • Collaborate with Clinical, Regulatory, Quality, Biostatistics and R&D Engineering to ensure aligned messaging and data interpretation • Conduct literature reviews and synthesize clinical data from multiple sources • Review and edit manuscripts for submission and publication in peer-reviewed journals • Translate complex scientific and clinical information into clear, concise and regulatory-compliance narratives • Support document strategy, timelines and regulatory submissions (e.g. FDA, PMA, CE marking technical documentation) • Involved in responses to complex queries such as those issued by notified bodies and stakeholder • Maintain document consistency, version control, and audit readiness • Contribute to SOP development and process improvements

United States
Job Closed
Pulse Biosciences, Inc. logo

Therapy Development Manager

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Therapist93 days ago
Full TimeRemoteLeadTeam 51-200Since 2016H1B No Sponsor

• Act as a technical expert of procedures and products. Provide effective training, presentations, and demonstrations to customers, utilizing strong communication and clinical expertise, to educate them on the application and use of the company's products. • Responsible for coordinating account(s) usage of proper reimbursement processes supporting procedure viability in the account(s). • Responsible for driving, increasing and fully supporting customer utilization of the nPulse Vybrance technology and meeting assigned territory goals. • Conduct educational events and develop relationships with support staff and local referring physicians to expand local awareness and referral networks for nPulse Vybrance. • Share best practices on procedure treatments, for various soft tissue types that the system is designed to treat. • Support unique needs of territory Key Opinion Leaders, which will be unique to the territory. • Educate customers on the indications, contraindications, and safety of nPulse Vybrance products, demonstrating how they meet customer needs. • Work with Company and account(s) in unique support and coordination role, including account initiated clinical studies, KOL scientific speaking engagements, account programs that support Company training programs and other initiatives consistent with supporting a Center-of-Excellence account(s). • Pre-plan clinical support calls, demonstrate efficient time management skills, and maintain a high level of customer service during customer interactions. • Develop and maintain up-to-date account files for the assigned region using the SalesForce.com CRM platform. • Conduct quarterly business reviews, strategic marketing activities and provide continued education and training to physicians, medical professionals, mid-levels, and office staff as necessary. • Share best practices with the entire territory development team and Pulse Biosciences management. • Establish a referral network (endocrine network) with regional nPulse Vybrance users, and other relationships that potentially enhance therapy development in support of account(s). • Stay updated on industry trends and competitive products. • Develop and maintain productive relationships at all levels within the organization. • Participate in industry-related trade shows and meetings. • Ensure compliance with quality and regulatory guidelines as an integral part of daily business operations. • Uphold high standards of integrity and honesty in interactions with customers and colleagues. • Complete administrative responsibilities including entering all weekly and monthly data into the CRM platform spreadsheet in a timely manner. Create and maintain business plans, submit weekly expense reports, and update account profiles regularly. • Participate in the development of training content for clinical team and physicians relative to the application and use of the company’s product. • Foster a culture of cross-functional collaboration, continuous learning, and integrity within the organization. • Comply with Pulse Biosciences quality system requirements and relevant regulatory requirements. • Adhere to health and safety regulations, policies, and work practices.

Florida
Job Closed
Pulse Biosciences, Inc. logo

Senior Clinical Research Associate, Cardiac Surgical Products

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Research Analyst109 days ago
Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Provides case support to research sites across multiple studies with minimal guidance. • Prepares and develops project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries. • Coordinates review of data listings and preparation of interim and final clinical study reports. • Responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data. • Responsible for developing study specific monitoring tools and other related documents. • Delivers high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plans. • Ensures that all missing action items (MAIs) from monitoring visits are closed within the timelines of monitoring plans. • Responsible for reviewing and approving essential regulatory documents across multiple studies. • Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial. • Oversees clinical data to ensure queries are closed within stipulated timelines of study goals • Provides clinical support for submission of trials to IRB/IEC and regulatory authorities. • Ensures adherence to study timeline across multiple studies. • Coaches and mentors other Clinical Research Associates (CRAs) in development and training. • Maintains strong working knowledge of protocols and product development across multiple studies. • Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team. • Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations. • Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study. • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. • Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies. • Manage Protocol Deviation documentation, tracking, and escalation. • Participates in site audits, as requested. • May perform other duties as assigned.

United States
Job Closed
Pulse Biosciences, Inc. logo

Senior Clinical Database Programmer/Analyst

Pulse Biosciences, Inc.

Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.

Software Engineer121 days ago
Full TimeRemoteSeniorTeam 51-200Since 2016H1B No Sponsor

• Create and develop clinical databases and data transfer files according to written specifications. • Develop and evaluate database configurations, including edit checks, derivations, and form/field dynamics in collaboration with Clinical Data Management. • Troubleshoot complex database issues and analyze data to identify trends and patterns. • Handle pre-processing and loading of non-CRF data files. • Assume responsibility for all DM activities (from study start-up to database lock) within project timelines including but not limited to data reviews, resolving data discrepancies, performing UAT, authoring/reviewing data management documentation (Data Management Plans, Data Review Guidelines, eCRFs, clinical database specifications and snapshot forms). • Manage programming data exports from various sources, developing complex subject profiles/cohorts, and creating listings in multiple output formats like PDF and XML. • Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications. • Assist with producing reports, tables, listings, and figures for clinical study reports (CSRs) and publications. • Develop safety datasets for trial level reporting for submission to regulatory agencies. • Create high level presentations that represent clinical data outcomes for Clinical Affairs management on a monthly basis. • Collaborate with the project team to ensure that deliverables are completed on time with high quality. • Maintain all project documentation as required by SOP and Processes.

United States
Job Closed