TalentBurst, an Inc 5000 companySr Analyst, Clinical Data Management
Irvine, CA (100% Onsite)
Duration: 6+ Months Contract with high possibility of extension/conversion
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.
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 computer skills in Microsoft Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
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 resolutionAssist 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.
¿Te interesa este puesto?