Jeremy Moyer

About Jeremy Moyer

If your clinical program is facing delays, operations bottlenecks, or compliance risks, I help sponsors get studies back on track, while staying on time and on budget.I help emerging, biotech, medical device and sponsor teams accelerate clinical study execution, optimize monitoring, strengthen TMF quality, and resolve operational bottlenecks before they impact timelines or budgets.With 15+ years of experience spanning medical device, diagnostic, and biotech programs, I\'ve supported studies from first-in-human trials in Europe and Australia to IDE pivotal studies, post-market evaluations, and reimbursement focused evidence generation.My expertise combines hands-on clinical operations leadership with a practical, problem-solving approach, allowing me to step into complex programs and deliver measurable results. Key areas of focus include:• Study Start-Up Acceleration: Streamlining feasibility, site selection, and regulatory preparation to reduce delays and drive trial readiness.• TMF & Compliance Excellence: Implementing structured, audit-ready processes to minimize inspection risk and maintain regulatory compliance.• Monitoring & Operational Oversight: Optimizing oversight, vendor management, and data quality across multi-site, multi-geography studies.• Strategic Clinical Consulting: Advising sponsors on operational challenges, process improvement, and risk mitigation to enhance study efficiency.I have partnered with a range of companies, from early-stage biotechs to specialized medical device firms, helping them meet aggressive timelines, strengthen operational execution, and deliver high-quality study outcomes.If your clinical program needs targeted operational support, start-up acceleration, TMF or monitoring expertise, or short-term leadership to keep your study on track, I help teams move faster, stay compliant, and operate with confidence.

Experience

1. Director Clinical Affairs

   Emblok

   Jan 2019 — Present

   Leading the clinical operations department for multiple studies, spanning protocol development through study close-out. Supporting regulatory submissions, animal studies, and multi-site clinical programs.Key Responsibilities: • Direct all clinical operations activities across multiple studies (different stages), including study design, protocol and study plan development, site management, and overall trial execution. • Collaborate with regulatory teams on IDE submissions and ongoing FDA submissions to ensure compliance and regulatory readiness. • Oversee cross-functional teams (clinical, data management, clinical field operations, regulatory, and vendor partners) to optimize study workflows and timelines. • Provide operational leadership for animal and early-phase clinical studies, ensuring high-quality data capture, TMF maintenance, and milestone achievement. • Support strategic planning and process improvements to reduce operational risk, accelerate timelines, and enhance trial quality.

Education

• East Stroudsburg University of Pennsylvania

  M.S.

  2003 — 2004

• University of Lynchburg

  Bachelor of Science (BS)

  1999 — 2003

Skills

• Clinical
• Neurology
• Life Sciences
• Medical Diagnostics
• Clinical Development
• Pharmaceutical Industry
• Fda
• Gcp
• Cardiology
• Oncology
• Cardiac
• Rehabilitation
• Diagnostics
• Biotechnology
• Biomarkers
• Hardware Diagnostics
• Clinical Trials
• Physiology
• Lifesciences
• Cardiovascular Disease
• Ctms
• Heart Failure
• CRO
• Genomics
• Diabetes
• Medicine
• Medical Devices
• Clinical Research