Radiant Systems Inc · 18 hours ago
Clinical Data Management Specialist
Irvine, CA
Contract
Onsite
Senior Level
$45/hr - $54/hr
5+ years expRadiant Systems Inc is seeking a Sr Clinical Data Management Analyst to support CDM study start-up activities. The role involves developing database specifications, authoring test scripts, and preparing key CDM deliverables while ensuring compliance with regulations.
CRMInformation TechnologySoftware
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 are 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 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 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
Qualification
Required
Experience with CDM study startup activities will be prioritized
Medidata experience is required
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 are 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 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 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
Experience with Medidata EDC (Electronic Data Capture) systems required
Good computer skills in Microsoft Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Bachelor's Degree or equivalent
5+ years of experience required
Preferred
Experience with InForm EDC system preferred
Company
Radiant Systems Inc
Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
501-1000 employees
H1B Sponsorship
Radiant Systems Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Late StageLeadership Team
Rayn Kamesh
Head of Sales/Director, Strategic Partnership - MSP/VMS Accounts
Company data provided by crunchbase