MaxisAI Hiring Clinical Data Management Project Coordinator | Remote

MaxisAI, posted by Maxis Clinical Sciences, is hiring for the position of Clinical Data Management Project Coordinator (Zelta EDC & ECOA). This opportunity is suitable for candidates with 3–5 years of practical Clinical Data Management (CDM) experience in a sponsor, CRO, or regulated clinical research environment.

The selected candidate will coordinate clinical data management activities across assigned studies, support EDC database build activities, manage study documentation, coordinate User Acceptance Testing (UAT), and assist with data transfers and database milestones.

MaxisAI Recruitment 2026 – Job Details

Positions

Clinical Data Management Project Coordinator (Zelta EDC & ECOA)

The role involves providing day-to-day coordination and administrative support for clinical data management activities. Candidates will maintain study documentation, trackers, task plans, meeting records, and testing documentation while coordinating with internal teams, external data providers, and EDC vendors.

Job Responsibilities

• Create and maintain study workspaces, project plans, tasks, dependencies, owners, and target dates.
• Coordinate study startup activities, routine reviews, follow-ups, and project status updates.
• Prepare, update, version-control, and maintain Clinical Data Management documents, including Study Data Management Plans and Data Transfer Agreements.
• Attend CDM, EDC build, UAT, data-transfer, and vendor meetings.
• Prepare meeting minutes covering decisions, action items, owners, deadlines, risks, and unresolved questions.
• Support Sitero EDC build coordination, including CRF reviews, edit-check questions, UAT records, and vendor follow-ups.
• Coordinate data-transfer requirements, delivery planning, secure file-transfer access, and discrepancy follow-ups.
• Support SDTM mapping activities, database lock and unlock records, final export collection, and database archival.
• Maintain study documentation and approved records in shared workspaces and vTMF.
• Support CRF standards-library activities, controlled-document updates, work instructions, training materials, and process improvements.
• Coordinate system access requests for secure file-sharing platforms and other tools.
• Support Zelta eCOA study pilots, including design specifications, configuration, unit testing, UAT, issue tracking, and documentation.

Eligibility Criteria / Educational Qualifications

Candidates must meet the following requirements:

• Bachelor’s degree in Health Science, Life Science, Information Systems, Project Management, or a related field.
• Equivalent relevant experience may also be considered.
• 3–5 years of practical Clinical Data Management experience in a sponsor, CRO, or regulated clinical research environment.
• Experience supporting EDC study startup, database build review, UAT, defect retesting, post-production changes, or database lock activities.

Required Skills

• Clinical Data Management (CDM)
• Electronic Data Capture (EDC)
• Zelta EDC and ECOA
• User Acceptance Testing (UAT)
• Clinical Database Build Review
• Clinical Study Documentation
• Study Data Management Plans
• Data Transfer Agreements
• SDTM Concepts
• Database Lock and Unlock Activities
• Good Clinical Practice (GCP)
• Good Clinical Data Management Practices
• Clinical Data Quality and Inspection Readiness
• Microsoft 365: Outlook, Teams, Word, Excel, SharePoint, and Planner
• Project Coordination and Task Tracking
• Document Control and Version Management
• Cross-functional Communication

Preferred Qualifications

• Experience as a Zelta Database Designer.
• Experience as an IBM Clinical Development database developer.
• Experience designing Zelta ePRO/eCOA solutions.
• Familiarity with Veeva Vault or another electronic Trial Master File (eTMF).
• Familiarity with SDTM concepts and inspection-readiness expectations.