Pulse Biosciences, Inc.

Clinical Research

• 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.

Senior Biostatistician

Medical writer

• 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

Medical Writer

Therapist

• 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.

Therapy Development Manager

Research Analyst

• 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.

Senior Biostatistician

Medical Writer

Therapy Development Manager

Senior Clinical Research Associate, Cardiac Surgical Products