Senior Manager, Clinical Site Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the identification, development, engagement, activation, and performance support of clinical sites for IDE and post-market clinical initiatives.

• Implement the clinical site development strategy across designated sites and regions.

• Lead or assist with site feasibility evaluations, qualifications, initiation, activation, and readiness efforts.

• Cultivate relationships with investigators, referral networks, and institutions.

• Create tailored engagement, activation, and enrollment-support plans for each site.

• Assess and resolve operational, staffing, referral, scheduling, and patient access challenges.

• Establish referral pathways linking electrophysiology labs, cardiology practices, cardiac surgery programs, and associated clinical departments.

• Aid in patient identification, screening, and enrollment in line with approved protocols and regulatory standards.

• Participate in high-priority site activities and clinical cases as needed.

• Lead or assist in site education, investigator meetings, grand rounds, peer-to-peer programs, and sanctioned engagement initiatives.

• Monitor site commitments, milestones, enrollment goals, and overall performance.

• Conduct regular site visits and maintain an active presence in the field.

• Act as the primary contact for assigned sites.

• Collaborate with internal teams, CROs, clinical sites, Clinical Marketing, and Medical Affairs.

• Provide updates regarding site feasibility, readiness, investigator engagement, referral activities, enrollment, performance, and operational challenges.

• Maintain documentation in clinical trial management systems, CRM systems, and other authorized tools.

• Prepare feasibility reports, site development strategies, site visit summaries, follow-up plans, and status updates.

• Conduct activities in compliance with clinical protocols, informed consent mandates, Good Clinical Practice, IDE regulations, SOPs, and site policies.

• Assist with audits, inspections, and quality enhancement activities.

⛳️ Requirements

• Bachelor’s degree in a scientific, healthcare, nursing, business, or related field preferred; equivalent relevant experience may be accepted.

• 8+ years of progressive experience in clinical research, clinical site management, medical device field support, patient recruitment, healthcare operations, or a related area.

• Proven experience in clinical site identification, feasibility analysis, qualification, activation, enrollment, or investigator engagement.

• Preferred experience in a hospital, cardiac surgery, electrophysiology, interventional cardiology, or similar procedural clinical setting.

• Preferred experience supporting IDE, pivotal, post-market, or other regulated medical device clinical trials.

• Experience collaborating with principal investigators, research coordinators, physicians, nurses, or hospital administration.

• Previous experience in a CRO-supported clinical trial or matrixed clinical organization preferred.

• Familiarity with U.S. and/or EU clinical research environments preferred.

• Comprehensive understanding of clinical trial operations, clinical site development, feasibility, site activation, patient recruitment, and enrollment processes.

• Proficient knowledge of Good Clinical Practice, informed consent, patient privacy, and clinical site standards.

• Capable of evaluating site capabilities and identifying factors that may influence site readiness and study outcomes.

• Proficient in Microsoft Office Suite and comfortable with CRM, clinical trial management, electronic documentation, and communication systems.

• Willingness to travel approximately 50–70% of the time, including overnight and occasional international travel.

• Flexibility to work occasional evenings, weekends, or non-standard hours.

• Ability to work in hospital and procedural settings, including operating rooms and electrophysiology laboratories.

• Capacity 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.

• Opportunities for professional and personal growth and development.

• A respectful work environment with a commitment to diversity and inclusion.