Clinical Trial Manager

Key Responsibilities

• Clinical Trial Start-Up: Oversee site identification and selection, contract and budget negotiations, IRB submissions, site initiation, and investigator and site staff training.
• Study Execution: Manage clinical trial activities across multiple sites, supporting enrollment goals, protocol compliance, and effective collaboration with investigators and study coordinators.
• Clinical Monitoring: Develop and implement the monitoring strategy, conduct remote and on-site monitoring visits, and coordinate external monitoring resources as needed.
• Project and Budget Management: Track study timelines, budgets, milestones, and risk registers, communicating progress and potential challenges to the Chief Medical Officer.
• Clinical Systems and Data Management: Oversee essential study documentation and operational systems, including electronic trial master files (eTMF), electronic data capture (EDC), data review and cleaning, and protocol deviation management.
• Compliance and Inspection Readiness: Maintain audit readiness and support regulatory inspections, including FDA Bioresearch Monitoring (BIMO) inspections and IRB oversight requirements.
• SOP Development: Create, maintain, and improve sponsor-level standard operating procedures (SOPs) and work instructions covering clinical operations, monitoring, and data management.
• International Clinical Support: Provide operational support for European clinical investigations, ensuring alignment with applicable ISO 14155 standards and EU MDR requirements.
• Cross-Functional Collaboration: Partner with internal stakeholders, academic institutions, investigators, and specialized external providers to ensure effective study delivery and high-quality clinical data.

Required Qualifications

• Bachelor's degree or higher in life sciences, nursing, medicine, biomedical engineering, or a related discipline.
• At least five years of clinical research experience, including three or more years working with U.S. FDA-regulated medical device studies.
• Familiarity with clinical investigations involving software as a medical device (SaMD).
• Direct experience managing the complete IRB submission process, including initial applications and ongoing amendments to study documentation, such as the Clinical Investigation Plan (CIP) and Informed Consent Form (ICF).
• Demonstrated experience managing a U.S. multicenter clinical trial from start-up through enrollment and closeout in a sponsor-side environment without a full-service CRO.
• Working knowledge of FDA 21 CFR Parts 812, 50, 56, and 11, ICH-GCP, ISO 14155, and HIPAA requirements.
• Practical experience using EDC and eTMF platforms.
• Strong organizational and problem-solving skills, with the ability to prioritize effectively and adapt to changing timelines.
• Proven ability to build relationships and manage stakeholders across academic research centers, healthcare systems, and senior clinical investigators or key opinion leaders (KOLs).
• Strong commitment to patient safety, data integrity, and regulatory compliance.
• Professional fluency in English.
• Authorization to work in the United States.

Preferred Qualifications

• Experience supporting clinical trials in cardiology, cardiovascular medicine, or heart failure.
• Background in pragmatic trials or studies integrated into routine clinical care or health system workflows.
• Experience with app-based clinical studies or remote patient monitoring, including patient onboarding, adherence management, and technical support.
• Involvement in preparing clinical evidence for FDA De Novo, 510(k), or Premarket Approval (PMA) submissions.
• Advanced degree, such as an MSc or equivalent.