Sr. Manager, Clinical Site Development

Pulse Biosciences

4d•Onsite

About The Position

The Sr. Manager, Clinical Site Development leads the identification, development, engagement, activation, and performance support of clinical sites for the Company’s IDE and post-market clinical programs. This field-based role works closely with investigators, research coordinators, physicians, nurses, hospital administrators, Field Clinical Engineers, and the In-House Clinical team to establish strong site relationships and support successful clinical study execution. The Sr. Manager, Clinical Site Development executes site development and enrollment-support activities within an assigned territory or group of clinical sites. The position evaluates potential clinical sites, develops investigator and referral relationships, supports site qualification and activation, establishes enrollment pathways, and addresses operational barriers that may affect study performance. The successful candidate will have experience in medical device clinical trials, clinical research, clinical site management, patient recruitment, cardiac surgery, electrophysiology, interventional cardiology, or a related healthcare environment.

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.
Strong relationship-building, communication, organization, follow-up, and problem-solving skills.
Ability to communicate professionally and effectively with investigators, site personnel, patients, referral partners, and internal stakeholders.
Ability to work independently, exercise sound judgment, and maintain close coordination with a geographically dispersed team.
Ability to manage multiple sites, priorities, travel schedules, and follow-up activities.
Strong attention to detail and commitment to accurate documentation and data quality.
Ability to operate with urgency while maintaining patient safety, protocol compliance, and professional judgment.
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, depending on assigned territory and business needs.
Ability to work occasional evenings, weekends, or nonstandard hours to support site activities, training, meetings, or clinical cases.
Ability to work in hospital and procedural environments, including operating rooms, electrophysiology laboratories, and other clinical areas, in accordance with site requirements.
Ability to lift and carry up to 15 pounds.

Responsibilities

Execute the clinical site development strategy across assigned sites and territories, identifying, assessing, and prioritizing sites based on investigator experience, patient population, procedural volume, staffing, facilities, research infrastructure, and ability to meet study requirements.
Lead or support site feasibility assessments, qualification activities, and the collection and analysis of information needed for site selection.
Develop and maintain relationships with potential and active investigators, research coordinators, physicians, nurses, hospital administrators, and other clinical stakeholders.
Identify appropriate investigators, referral networks, and institutional partners for the Company’s clinical programs.
Develop site-specific engagement, activation, and enrollment-support plans.
Evaluate operational, staffing, referral, scheduling, and patient access barriers that may affect site activation, enrollment, or ongoing performance.
Recommend and implement practical, compliant solutions to address site development and enrollment challenges, with appropriate approval and oversight.
Maintain regular communication with prospective and active clinical sites and provide timely updates to senior management as directed.
Lead or support site initiation, activation, and readiness activities in collaboration with the In-House Clinical team, Clinical Research Associates, Clinical Project Managers, CRO personnel, and site staff.
Establish and strengthen appropriate referral pathways among electrophysiology laboratories, cardiology practices, cardiac surgery programs, and other relevant clinical departments.
Support site teams in identifying potential trial candidates in accordance with the approved protocol and applicable regulatory requirements.
Coordinate patient identification, screening, and enrollment-support activities within the scope of approved training, delegated responsibilities, and Company procedures.
Attend high-priority site activities and clinical cases, as appropriate, to support coordination among the site, clinical team, and Company personnel.
Lead or support site education, investigator meetings, grand rounds, peer-to-peer programs, and other approved activities designed to strengthen site engagement and clinical program awareness.
Monitor site commitments, milestones, and performance against agreed-upon development and enrollment objectives.
Escalate potential enrollment barriers, protocol questions, patient safety concerns, site performance concerns, and other issues promptly to the Director, Clinical Site Development and appropriate clinical leadership.
Establish and maintain professional, productive relationships with principal investigators, sub-investigators, research coordinators, physicians, nurses, operating room personnel, and hospital administrators.
Conduct routine site visits and maintain an appropriate field presence based on site development priorities and direction from the Director, Clinical Site Development.
Serve as a primary point of contact for assigned sites while ensuring that communication remains coordinated with the In-House Clinical team and other Company stakeholders.
Maintain awareness of investigator and site needs, capabilities, resource constraints, and development opportunities.
Support site retention and continued engagement through responsive communication, appropriate follow-up, and effective issue escalation.
Identify opportunities to improve site performance, enrollment readiness, referral activity, and long-term site relationships.
Ensure all site interactions are consistent with Company policies, clinical trial requirements, applicable laws, and professional standards.
Work closely with internal cross-functional teams to coordinate site identification, qualification, activation, enrollment, and performance-support activities.
Collaborate with internal and external stakeholders, including CROs, and clinical sites, to coordinate clinical activities, site communication, case schedules, procedural support, and related logistics to promote consistent clinical trial execution.
Partner with Clinical Marketing, Medical Affairs, and other internal stakeholders on approved investigator, site education, and clinical program activities.
Ensure field activities complement ongoing clinical operations and do not create duplicative, conflicting, or unauthorized communications with clinical sites.
Participate in site review meetings, feasibility reviews, enrollment planning sessions, investigator meetings, and other operational forums as requested.
Provide timely, accurate updates on potential sites, site feasibility, site readiness, investigator engagement, referral activity, enrollment status, site performance, and operational barriers.
Maintain accurate records in approved clinical trial management systems, customer relationship management systems, and other Company tools.
Prepare site feasibility reports, site development plans, site visit summaries, follow-up plans, and status updates.
Provide field-level insights to support site forecasts, development priorities, enrollment projections, and performance reviews, escalating progress, delays, and risks to management and appropriate stake holders.
Conduct all activities in accordance with the approved clinical trial protocol, informed consent requirements, Good Clinical Practice, applicable IDE requirements, Company SOPs, and site policies.
Complete required training and maintain all applicable certifications and qualifications.
Support audit, inspection, and quality-improvement activities as requested.