Impactful Clinical Trials Analyst

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 59,000 - 83,000; Full time

Job summary

Edwards Lifesciences is seeking a Clinical Trial Management professional to join our on-site team in Irvine, CA. You will collaborate with sites, stakeholders, and regulatory bodies to ensure data integrity and trial efficiency while supporting device accountability processes.

The role requires a Bachelor’s degree and 1 year of trial management experience, with familiarity in JD Edwards, Salesforce, and CTMS. Travel up to 5% may be required as part of oversight and site visits.

Qualifications

• Bachelor’s degree in a related field with 1 year of clinical trial management experience.
• Experience with regulatory documents and clinical trial master files (TMFs).
• Experience with JD Edwards, Salesforce, CTMS is preferred.
• Strong written and verbal communication, and cross-functional collaboration.

Responsibilities

• Communicate regularly with sites and field team to resolve basic queries.
• Investigate discrepancies between site and JDE data on device accountability with stakeholders.
• Provide training on device accountability in electronic databases (Salesforce) for cross-functional teams.
• Identify and implement process improvements to trial workflows and device data.
• Partner with Quality to resolve device-related issues.
• Prepare and compile regulatory data for submission to authorities (FDA).
• Assist with other incidental duties.

Skills

Clinical trial management

ERP JD Edwards

Salesforce

CTMS

Attention to detail

Problem solving

Organizational skills

Analytical skills

Communication skills

Team collaboration

MS Office

Regulatory knowledge (GCP, GDP)

TMF knowledge

Regulatory documentation

Travel readiness

Education

Bachelor’s degree in related field

Tools

eTMF system

CTMS software

CRM (Salesforce)

Job description

Edwards Lifesciences is seeking a Clinical Trial Management professional to join our on-site team in Irvine, CA. You will collaborate with sites, stakeholders, and regulatory bodies to ensure data integrity and trial efficiency while supporting device accountability processes.

The role requires a Bachelor’s degree and 1 year of trial management experience, with familiarity in JD Edwards, Salesforce, and CTMS. Travel up to 5% may be required as part of oversight and site visits.