Senior Clinical Data Management Analyst — Hybrid Irvine

TalentBurst, Inc; Irvine (CA); Hybrid; USD 83,000 - 117,000; Full time

Job summary

TalentBurst, Inc. is seeking a Sr Analyst, Clinical Data Management in Irvine, CA (hybrid) for a 6+ month contract with a strong potential for extension or conversion. The role focuses on supporting study start-up activities, including database specifications, test script authoring, and key CDM deliverables.

The candidate should have a Bachelor’s degree or equivalent, 5–7 years of CDM experience, and Medidata EDC expertise. Strong communication and problem-solving skills are required.

Qualifications

• Bachelor's Degree or equivalent.
• 5-7 years of experience required.
• Experience with CDM study startup activities will be prioritized. Medidata experience is required.
• Experience with Medidata EDC (Electronic Data Capture) systems required. InForm EDC system experience preferred.
• Strong written and verbal communication skills and interpersonal relationship skills.
• Strong problem-solving and critical thinking skills.

Responsibilities

• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks) for assigned studies and coordinate user acceptance testing.
• Maintain and develop Data Management deliverables including DMPs, CRF completion guidelines, and training materials.
• Perform Site/User Administration including generating and validating EDC reports and Subject PDFs.
• Evaluate data errors and collection issues; provide guidance to the clinical team for resolution.
• Assist in leading project management activities for a cohort or project to bring clinical studies online.
• Develop and review SOPs, work instructions, and associated documents for CDM, and participate in user training.

Skills

CDM domain knowledge

Medidata EDC

Communication skills

Problem solving

Education

Bachelor's Degree or equivalent

Tools

Medidata

InForm EDC

Job description

TalentBurst, Inc. is seeking a Sr Analyst, Clinical Data Management in Irvine, CA (hybrid) for a 6+ month contract with a strong potential for extension or conversion. The role focuses on supporting study start-up activities, including database specifications, test script authoring, and key CDM deliverables.

The candidate should have a Bachelor’s degree or equivalent, 5–7 years of CDM experience, and Medidata EDC expertise. Strong communication and problem-solving skills are required.