Clinical Affairs Manager, CRB Case Planning & Strategy

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

JenaValve Technology, Inc. seeks a Manager, Clinical Affairs (CRB) to lead case planning for global clinical trials. You will work with Field Clinical Specialists, site coordinators, and core labs to develop and improve CRB processes while mentoring junior staff.

The role requires strong regulatory knowledge (GCP, ISO 14155, ICH) and experience in medical devices. This position offers remote work with global collaboration across time zones.

Qualifications

• 5+ years of relevant professional experience in clinical operations, site management, case planning, patient screening, etc.
• Advanced degree in a biological science / pharmacy / nursing is desired.
• Strong knowledge of regulatory guidelines governing clinical trials.

Responsibilities

• Drive scheduling and executing CRB meetings with committee members and site-level health care providers across all clinical trials.
• Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites.
• Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency.
• Preparation and review of presentation materials for CRB meetings for all clinical trials with site clinical research coordinators, implanters, and field clinical specialists.
• Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases.
• Develop and maintain the CRB charters as needed.
• Manage and troubleshoot imaging upload and transfer workflow.

Skills

GCP knowledge

Medical device regulations 2017/745

ISO 14155

ICH Guidelines

Process improvement

Cross-functional collaboration

Leadership

Education

Advanced degree in biological science / pharmacy / nursing

Tools

PowerPoint

Excel

Zoom / Teams

Job description

JenaValve Technology, Inc. seeks a Manager, Clinical Affairs (CRB) to lead case planning for global clinical trials. You will work with Field Clinical Specialists, site coordinators, and core labs to develop and improve CRB processes while mentoring junior staff.

The role requires strong regulatory knowledge (GCP, ISO 14155, ICH) and experience in medical devices. This position offers remote work with global collaboration across time zones.