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Senior Manager, Clinical Site Development
Pulse Biosciences, Inc.. Lead identification, development, engagement, activation, and performance support of clinical sites for IDE and post-market clinical programs .
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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