Infosoft, Inc. · 9 hours ago
Sr Clinical Data Management Analyst
Irvine, CA
Full-time
Hybrid
Senior Level
$50/hr - $54/hr
5+ years expInfosoft, Inc. is a global medical device manufacturer seeking a Senior Clinical Data Management Analyst. The role involves supporting clinical data management study start-up activities, developing database specifications, and preparing key deliverables while ensuring compliance with regulations.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Chandan Kumar (Jeet)
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 online, including conducting project team meetings, establishing and maintaining project timelines, and communicating with stakeholders
Participate in the development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, and participating in the development of user training
Qualification
Required
Bachelor's Degree or equivalent with 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
Good computer skills in the Microsoft Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Preferred
Experience with the InForm EDC system preferred
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
H1B Sponsorship
Infosoft, 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
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Trends of Total Sponsorships
2025 (17)
2024 (37)
2023 (10)
2022 (14)
2021 (19)
2020 (23)
Funding
Current Stage
Growth StageCompany data provided by crunchbase