Senior Manager, Clinical Site Development

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Pulse Biosciences, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

💼 Consulting

🏭 Manufacturing

🏥 Healthcare

Consulting • Manufacturing • Healthcare

Pulse Biosciences, Inc. is a pioneering company in bioelectric medicine, specializing in the development of its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology for healthcare applications. The company focuses primarily on innovative treatments in cardiology, particularly for conditions such as atrial fibrillation, utilizing their CellFX platform to improve patient outcomes. Through rigorous research and development, Pulse Biosciences aims to enhance cardiac care, offering groundbreaking solutions that promise safer and more effective treatment options across various therapeutic areas.

📋 Description

• Lead identification, development, engagement, activation, and performance support of clinical sites for IDE and post-market clinical programs • Execute clinical site development strategy across assigned sites and territories • Lead or support site feasibility assessments, qualification, site initiation, activation, and readiness activities • Develop investigator, referral network, and institutional relationships • Develop site-specific engagement, activation, and enrollment-support plans • Evaluate and address operational, staffing, referral, scheduling, and patient access barriers • Establish referral pathways among electrophysiology laboratories, cardiology practices, cardiac surgery programs, and relevant clinical departments • Support patient identification, screening, and enrollment in accordance with approved protocols and regulatory requirements • Attend high-priority site activities and clinical cases as appropriate • Lead or support site education, investigator meetings, grand rounds, peer-to-peer programs, and approved engagement activities • Monitor site commitments, milestones, enrollment objectives, and performance • Conduct routine site visits and maintain field presence • Serve as primary point of contact for assigned sites • Collaborate with internal teams, CROs, clinical sites, Clinical Marketing, and Medical Affairs • Provide updates on site feasibility, readiness, investigator engagement, referral activity, enrollment, performance, and operational barriers • Maintain records in clinical trial management systems, CRM systems, and other approved tools • Prepare feasibility reports, site development plans, site visit summaries, follow-up plans, and status updates • Conduct activities in accordance with clinical protocols, informed consent requirements, Good Clinical Practice, IDE requirements, SOPs, and site policies • Support audits, inspections, and quality-improvement activities

🎯 Requirements

• Bachelor’s degree in a scientific, healthcare, nursing, business, or related discipline preferred; equivalent relevant experience may be considered • 8+ years of progressive experience in clinical research, clinical site management, medical device field support, patient recruitment, healthcare operations, or a related field • Demonstrated experience with clinical site identification, feasibility, qualification, activation, enrollment, or investigator engagement • Experience working in a hospital, cardiac surgery, electrophysiology, interventional cardiology, or other procedural clinical environment preferred • Experience supporting IDE, pivotal, post-market, or other regulated medical device clinical studies preferred • Experience working with principal investigators, research coordinators, physicians, nurses, or hospital administration • Experience working in a CRO-supported clinical trial or matrixed clinical organization preferred • Familiarity with U.S. and/or EU clinical research environments preferred • Strong understanding of clinical trial operations, clinical site development, feasibility, site activation, patient recruitment, and enrollment processes • Working knowledge of Good Clinical Practice, informed consent, patient privacy, and clinical site standards • Ability to assess site capabilities and identify factors that may affect site readiness and study performance • Proficient in Microsoft Office Suite and comfortable using CRM, clinical trial management, electronic documentation, and communication systems • Ability to travel approximately 50–70% of the time, including overnight travel and periodic international travel • Ability to work occasional evenings, weekends, or nonstandard hours • Ability to work in hospital and procedural environments, including operating rooms and electrophysiology laboratories • Ability to lift and carry up to 15 pounds

🏖️ Benefits

• A variety of health insurance plans and supplemental insurance options • 401k retirement savings plan • Stock option awards • Employee Stock Purchase Plan (ESPP) • Paid time off • Paid holidays • Flexible work schedule • Wellness program, including onsite gym and mindfulness classes • Professional and personal growth and development opportunities • Respectful work environment and commitment to diversity and inclusion