Clinical Data Management Specialist

Mindlance; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Mindlance is seeking a Clinical Data Analyst to lead and support clinical data management from study start-up through closeout, including database lock.

The role requires defining eCRFs/CRFs, data quality assessment, and leading online project activities with timelines and stakeholder communications. Strong EDC experience and clear communication are essential; familiarity with AI tools is a plus. Equal opportunity employer and supportive for growth, based in Irvine, CA.

Qualifications

• Experience with EDC systems (Classic and Medidata RAVE).
• Strong written and verbal communication skills.
• Good problem-solving and critical thinking abilities.
• Experience using AI tools like CoPilot, Claude preferred.

Responsibilities

• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks) for assigned studies and coordinate testing.
• Evaluate data errors and collection issues; provide guidance to clinical team for resolution.
• Lead project management activities for clinical studies online, including meetings and timelines.
• Maintain and develop Data Management deliverables (DMPs, training materials, user aids).
• Perform User Access and data reconciliation (external and internal).
• Experience with Trial Master File (TMF) for clinical trial documentation.
• Review SOPs and work Instructions for CDM; assist in SOP revisions and user training.

Skills

EDC systems experience

Communication skills

Problem-solving

AI tools in clinical trials

Education

Bachelor's degree or equivalent

Tools

Medidata RAVE / EDC

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.

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 on-line, 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.

Skills:

• Experience with EDC (Electronic Data Capture) systems required, both Classic and New Medidata RAVE EDC.
• Good written and verbal communication skills and interpersonal relationship skills.
• Good problem-solving and critical thinking skills.
• Experience with using AI tools like CoPilot, Claude to support clinical trial activities is preferred.

Education and Experience:

• Bachelor's Degree or equivalent.
• 2-4 years of experience required.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”