Pulse Biosciences, Inc.
Pulse Biosciences, Inc.
Pulse Biosciences, Inc. денсаулық сақтау саласында қолдануға арналған биоэлектрлік медицина технологияларын әзірлейді. Компанияның меншікті Nanosecond Pulsed Field Ablation (nsPFA) технологиясы жүрек денсаулығын жақсартуға, соның ішінде жүрекшелер фибрилляциясын емдеуге бағытталған CellFX платформасының негізі болып табылады. Компания емдеу салаларындағы жаңа тәсілдерді дамыту үшін ғылыми-зерттеу және тәжірибелік-конструкторлық жұмыстарды медициналық құрылғылар өндірумен ұштастырады.

Senior Manager, Clinical Site Development

Lead clinical site development for Pulse Biosciences’ bioelectric medicine trials, from investigator engagement and site activation through enrollment support. This remote U.S. role partners with clinical teams and healthcare institutions across regulated programs.

Сипаттама

  • Lead the identification, development, engagement, activation, and performance support of clinical sites for IDE and post-market programs.
  • Implement clinical site development strategies across assigned territories and sites.
  • Lead or contribute to feasibility reviews, site qualification, initiation, activation, and readiness activities.
  • Build relationships with investigators, referral networks, and healthcare institutions.
  • Create site-specific plans for engagement, activation, and enrollment support.
  • Identify and resolve operational, staffing, referral, scheduling, and patient-access constraints.
  • Build referral pathways across electrophysiology laboratories, cardiology practices, cardiac surgery programs, and relevant clinical departments.
  • Support patient identification, screening, and protocol-compliant enrollment in accordance with regulatory requirements.
  • Attend priority site activities and clinical cases when appropriate.
  • Lead or support site training, investigator meetings, grand rounds, peer-to-peer programs, and approved engagement activities.
  • Track site commitments, milestones, enrollment targets, and performance.
  • Conduct regular site visits and maintain an active field presence.
  • Act as the primary contact for assigned clinical sites.
  • Partner with internal teams, CROs, clinical sites, Clinical Marketing, and Medical Affairs.
  • Report on feasibility, readiness, investigator engagement, referral activity, enrollment, performance, and operational obstacles.
  • Keep records current in clinical trial management, CRM, and other approved systems.
  • Prepare feasibility reports, site development plans, visit summaries, follow-up plans, and status reports.
  • Perform all activities in line with clinical protocols, informed consent requirements, Good Clinical Practice, IDE requirements, SOPs, and site policies.
  • Support audits, inspections, and quality-improvement initiatives.

Талаптар

  • Bachelor’s degree in a scientific, healthcare, nursing, business, or related field preferred; equivalent relevant experience may be considered.
  • At least 8 years of progressive experience in clinical research, clinical site management, medical device field support, patient recruitment, healthcare operations, or a related area.
  • Demonstrated experience identifying, assessing, qualifying, activating, and supporting clinical sites, enrollment, or investigator engagement.
  • Experience in a hospital, cardiac surgery, electrophysiology, interventional cardiology, or comparable procedural clinical setting preferred.
  • Experience supporting IDE, pivotal, post-market, or other regulated medical device studies preferred.
  • Experience collaborating with principal investigators, research coordinators, physicians, nurses, or hospital administrators.
  • Experience in CRO-supported trials or matrixed clinical organizations preferred.
  • Familiarity with U.S. and/or EU clinical research settings preferred.
  • Strong knowledge of clinical trial operations, site development, feasibility, activation, patient recruitment, and enrollment.
  • Working knowledge of Good Clinical Practice, informed consent, patient privacy, and clinical site standards.
  • Ability to evaluate site capabilities and identify factors affecting readiness and study performance.
  • Proficiency with Microsoft Office and comfort using CRM, clinical trial management, electronic documentation, and communications systems.
  • Willingness and ability to travel approximately 50–70%, including overnight and occasional international travel.
  • Availability for occasional evening, weekend, or other nonstandard hours.
  • Ability to work in hospital and procedural settings, including operating rooms and electrophysiology laboratories.
  • Ability to lift and carry up to 15 pounds.

Артықшылықтар

  • Multiple health insurance plans and supplemental coverage options.
  • 401(k) retirement savings plan.
  • Stock option awards.
  • Employee Stock Purchase Plan (ESPP).
  • Paid time off.
  • Paid holidays.
  • Flexible work schedule.
  • Wellness program with an onsite gym and mindfulness classes.
  • Professional and personal development opportunities.
  • Respectful workplace with a commitment to diversity and inclusion.

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