Clinical Program Manager

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

📋 Description

• Act as a vital operational collaborator with the Head of Clinical Affairs.

• Oversee the complete execution of designated clinical programs, such as WiSE-UP, SOLVE, and other clinical studies.

• Manage study initiation, site activation, timelines, budgets, and coordination with CROs/vendors.

• Develop and uphold dashboards and reporting tools for program status, site enrollment, data quality, and unresolved action items.

• Facilitate the utilization of real-world evidence derived from registries, EMR, and claims data.

• Recognize deficiencies in data quality, site compliance, processes, or team capacity and lead efforts to resolve them.

• Direct cross-functional teams across Clinical, Regulatory, Sales, Field Clinical Engineering, Marketing, and Post Market Surveillance.

• Prepare and submit regular clinical study progress reports to the FDA in collaboration with Regulatory Affairs.

• Manage relationships with research sites and liaise with CROs and regulatory agencies.

• Observe site performance and compliance, addressing documentation, reporting, and data quality concerns.

• Create and maintain SOPs, templates, and program documentation.

• Design and conduct training for clinical research personnel and site coordinators.

• Monitor study budgets and forecasts, detect variances, and manage program expenditures with Finance.

• Prepare program updates, executive summaries, and clinical program updates for the Board.

• Develop, implement, and sustain clinical study protocols in compliance with GCP and regulatory standards.

• Identify and manage clinical program risks, including escalation and mitigation strategies.

• Ensure adherence to FDA regulations, EBR Systems policies, and study protocols.

• Supervise Clinical Program Coordinators, study managers, and/or Clinical Research Associates as assigned.

• Engage in hiring, training, work planning, performance evaluations, and problem resolution.

⛳️ Requirements

• Bachelor's degree in life sciences, biomedical engineering, nursing, or a related discipline is required.

• Over 7 years of experience in medical device clinical affairs, clinical operations, or clinical program/project management.

• Experience in the cardiovascular or cardiac rhythm management (CRM) field is preferred.

• Proven track record of managing clinical programs or studies from start to finish, including site initiation, timelines, budgets, and CRO/vendor coordination.

• Familiarity with Good Clinical Practice (GCP) guidelines, clinical research methodology, and relevant regulatory standards.

• Clinical/technical understanding of cardiac implantable electronic devices (CIEDs) and CRM/electrophysiology concepts.

• Demonstrated ability to create and sustain dashboards and reporting tools; proficiency in Excel and Monday.com is necessary.

• Strong leadership capabilities across functions.

• Exceptional written and verbal communication skills.

• Proficiency in Microsoft Office (Excel, PowerPoint, Word) and clinical data tracking tools.

• Strong skills in protocol development, technical writing, and data analysis.

• Attention to detail along with effective risk management and quality assurance practices.

• Ability to translate strategy into actionable programs with specified milestones.

• Familiarity with FDA regulations and guidance pertinent to clinical study execution.

• Willingness to travel up to 30% of the time.

• Capacity to lift up to 20 pounds.

• PMP certification is a plus.

• Familiarity with Zelta, Power BI, and Salesforce is advantageous.

• Knowledge of real-world evidence sources is a plus.

🏝️ Benefits

• Competitive compensation.

• Equity opportunities.

• Comprehensive benefits package.

• Generous paid time off (PTO).

• Medical, dental, and vision insurance provided at no cost for employee-only coverage.

• 401(k) matching program.

• Paid Time Off starting at 3 weeks per year.

• Competitive salary with pathways for career advancement.

• Employee stock options.

• Life and AD&D insurance, along with long-term disability coverage.

• Education assistance available.

• Optional commuter benefits and pet insurance.

• Weekly company lunches and occasional happy hour events.

• Opportunities for meaningful work and personal growth.