Clinical Data Analyst
Irvine, CA - USA
Job Summary
Position: Clinical Data Analyst Req# 19151-1
Location: Irvine CA(2 days onsite 3 days remote)
Duration: 12 months contractto hire
Job Description:
The main function of a clinical data analyst is to lead and support clinical data management activities during study start-up conduct and closeout including database lock.
Education and Experience:
- Bachelors Degree or equivalent.
- 2-4 years of experience required.
Skills:
- Experience with EDC (Electronic Data Capture) systems required both Classic and New Medidata RAVE EDC.
- Good computer skills in Microsoft Office Suite.
- Good written and verbal communication skills and interpersonal relationship skills.
- Good problem-solving and critical thinking skills.
- Experience using AI tools like Copilot and Claude to support clinical trial activities is preferred.
Key Responsibilities:
- Define and specify clinically data collection requirements (e.g. eCRFs CRFs edit checks and collection of external data) for assigned studies; including defining performing using Global Library standards and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
- Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
- Lead project management activities for clinical studies online including conducting project team meetings establishing and maintaining project timelines and communications to stakeholders.
- Maintain and develop Data Management deliverables including data management plans (DMPs) training materials and user aids in compliance with regulations.
- Perform User Access and data (external and internal) reconciliation.
- Experience with Trial Master File (TMF) for clinical trial documentation and filing.
- Participate in review of SOPs work instructions and associated documents for CDM including recommending revisions and updates to SOPs participating in the development of user training.
Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Required Experience:
IC
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more