Senior Clinical Trial Manager - Medical Devices

Socket.dev; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Paid time off

Vision insurance

Job summary

Socket.dev in Irvine, CA is seeking a Clinical Project Manager to oversee end-to-end clinical studies for medical devices, including IDEs and post-market trials. You will manage CROs, Core Lab vendors, budgets, timelines, and study deliverables, ensuring patient safety, data integrity, and regulatory compliance.

Collaborate with Clinical Research Associates, Data Management, Biostatistics, and other teams to produce study documents and maintain up-to-date knowledge of relevant literature.

Qualifications

• Solid working knowledge of GCP/ICH guidelines, FDA regulations, and the IDE/IRB submission and reporting process.
• Strong project management skills – scope, budget, timeline, and resource management.
• Comfortable negotiating vendor contracts and managing site budgets.
• Strong written and verbal communication skills with the ability to clearly present information to leadership, KOLs, and investigators.
• Highly organized with ability to manage multiple studies and competing priorities at once.
• Proficient with CTMS, EDC systems, and standard MS Office tools.

Responsibilities

• Lead end-to-end clinical study management from feasibility to closeout.
• Oversee CROs, Core Labs, and vendors including contracts and budgets.
• Coordinate with cross-functional teams to ensure protocol adherence.
• Manage study budgets, timelines, and deliverables.
• Prepare regulatory documents and IDE/IRB submissions.
• Provide regular updates to leadership and study teams.
• Ensure compliance with GCP/ICH and FDA regulations.

Skills

GCP/ICH knowledge

Project management

Vendor contract negotiation

Communication skills

Organization

CTMS/EDC proficiency

MS Office proficiency

Education

Bachelor's degree in life sciences, nursing, engineering, or related field

Advanced degree a plus

Tools

CTMS

EDC systems

MS Office

Job description

Socket.dev in Irvine, CA is seeking a Clinical Project Manager to oversee end-to-end clinical studies for medical devices, including IDEs and post-market trials. You will manage CROs, Core Lab vendors, budgets, timelines, and study deliverables, ensuring patient safety, data integrity, and regulatory compliance.

Collaborate with Clinical Research Associates, Data Management, Biostatistics, and other teams to produce study documents and maintain up-to-date knowledge of relevant literature.