CRA Manager - Clinical Operations & Site Oversight

Jenavalve Technology; Irvine (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Jenavalve Technology is looking for a CRA Manager in Irvine, California, to lead a team in clinical trial site management while ensuring high standards of data quality and regulatory compliance. This hybrid role requires both people management and operational oversight, serving as an essential link between the clinical operations team and external vendors.

The ideal candidate will need a bachelor’s degree in Life Sciences and at least 5 years of industry experience, ideally in medical devices. Responsibilities include performance management of site staff, driving compliance, and collaborating across various functions to ensure study success.

Qualifications

• Minimum of 5 years of clinical research experience in the medical device industry.
• Experience in a formal supervisory role preferred.
• Strong organizational skills with the ability to work independently.

Responsibilities

• Oversee site management activities across assigned trials to ensure compliance.
• Directly manage a team of Site Managers and oversee their performance.
• Support audits and ensure regulatory documentation compliance.

Skills

FDA regulatory framework knowledge

GCP understanding

SOP development

Project management skills

People management skills

Education

Bachelor’s degree in Life Sciences or related discipline

Tools

CTMS

EDC

eTMF

Job description

Jenavalve Technology is looking for a CRA Manager in Irvine, California, to lead a team in clinical trial site management while ensuring high standards of data quality and regulatory compliance. This hybrid role requires both people management and operational oversight, serving as an essential link between the clinical operations team and external vendors.

The ideal candidate will need a bachelor’s degree in Life Sciences and at least 5 years of industry experience, ideally in medical devices. Responsibilities include performance management of site staff, driving compliance, and collaborating across various functions to ensure study success.