Clinical Data Management Specialist

TalentBurst, an Inc 5000 company; Irvine (CA); Hybrid; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading analytics firm is seeking a Sr Analyst for Clinical Data Management to support study start-up activities. The role involves developing database specifications and authoring test scripts. Candidates should possess a Bachelor's Degree with 5-7 years of relevant experience, particularly in study startup activities, and familiarity with Medidata EDC systems. This position is based in Irvine, CA, and offers a hybrid work model, emphasizing strong communication and critical thinking skills.

Qualifikationen

• 5-7 years of experience in clinical data management.
• Experience with CDM study startup activities prioritized.
• Experience with Medidata EDC systems required.

Aufgaben

• Define data collection requirements for assigned studies.
• Maintain and develop sections of Data Management deliverables.
• Perform Site/User Administration including report validation.
• Evaluate data errors and provide guidance for resolution.
• Assist in project management activities for clinical studies.
• Participate in the development of SOPs and training.

Kenntnisse

Medidata EDC systems

Critical thinking

Written and verbal communication

Ausbildung

Bachelor's Degree or equivalent

Tools

InForm EDC system

Jobbeschreibung

Position: Sr Analyst, Clinical Data Management, Req#: 15762-1

Location: Irvine, CA (hybrid)

Duration: 6+ Months Contract with high possibility of extension/conversion

Job Description

The primary responsibility of the Clinical Data clinical data analyst is to support CDM study start‑up activities, including developing database specifications, authoring and executing test scripts, and preparing key CDM deliverables.

Education and Experience

• 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. Experience with the InForm EDC system preferred.
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills

Job 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, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data is collected.
• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with regulations.
• Perform Site/User Administration including generating and validating EDC reports and Subject PDFs.
• Evaluate data errors and collection issues; provide guidance and recommendations to the clinical team for resolution.
• Assist in leading project management activities for a cohort or project to bring clinical studies on‑line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Participate in the development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.