Clinical Data Analyst: Data Integrity & Regulatory Reporting

EDETEK, Inc.; Princeton (NJ); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, Vision and Dental Insurance

Paid vacation and sick days

Corporate holidays annually

401K Plan

Perks and discount programs

Job summary

EDETEK, Inc. is seeking a ClinicalDataAnalyst (or ClinicalInformaticsAnalyst) to ensure data accuracy across clinical trials, from planning through regulatory submission.

The role emphasizes validating data, ensuring compliance with regulations and company standards, and achieving analysis goals with quality and efficiency. The analyst will oversee data management activities, design reports, and coordinate with study management, clinical operations, and biostatistics to support robust data

Qualifications

• Ability to compile, code, and categorize data.
• Ability to handle multiple priorities and communicate with teams.
• Strong interpersonal and communication skills.
• Experience coordinating with study teams, data management, biostatisticians, and regulatory agencies.
• Creative thinking and attention to detail.

Responsibilities

• validating results and conclusions from clinical research
• overseeing external and internal data management activities
• expanding or modifying the system to serve new purposes and improve workflow
• designing clinical and administrative reports
• reviewing, extracting, compiling, and analyzing study data for compliance, quality, and accuracy, and undertaking quality improvement initiatives
• coordinating with other relevant departments to determine areas to be analyzed and ensure useful data analysis
• identifying necessary resources, developing plans for data-related projects, and determining timelines
• performing data validation, data reconciliation, and data surveillance
• conducting training for technical and software programs

Skills

Data compilation & categorization

Interpersonal & communication skills

Independent problem solving

Job description

EDETEK, Inc. is seeking a ClinicalDataAnalyst (or ClinicalInformaticsAnalyst) to ensure data accuracy across clinical trials, from planning through regulatory submission.

The role emphasizes validating data, ensuring compliance with regulations and company standards, and achieving analysis goals with quality and efficiency. The analyst will oversee data management activities, design reports, and coordinate with study management, clinical operations, and biostatistics to support robust data