Clinical Data Specialist

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. #J-18808-Ljbffr