Clinical Data Analyst

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

AClinicalDataAnalyst (orClinicalInformaticsAnalyst) is a clinical research information professional responsible for verifying the validity of clinical trials and data gathered.He/she will ensure that processes and protocols are followed, regulations and company standards are followed, and the analysis goals are achieved, with quality and efficiency.

AClinicalDataAnalyst’s primary responsibility is to ensure that data is accurate and reliable throughout the clinical trial conduct, analysis, and regulatory submission. The information collected and produced is free of errors, relevant, and sound. All in all, aClinicalDataAnalyst is at the center of data management for an organization, right from planning and execution to completion of a clinical study phase.

Essential Functions and 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 (e.g., study management team, clinical operations, clinical data management, and biostatistics) to determine the areas to be analyzed and see that appropriate measures are taken to ensure data analysis is useful
• identifying necessary resources, developing plans for data-related projects, and determining timelines and milestones
• performing data validation, data reconciliation, and data surveillance
• conducting training for technical and software programs

Education and Experience Required

• Ability to compile, code, and categorize data
• Ability to handle multiple priorities and explore innovative solutions to problems
• Strong interpersonal and communication skills
• Tackling complex situations involving study management and conduct teams, clinical data management, biostatisticians, and regulatory agencies.
• Creative thinking, an eye for detail, working independently.

Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.

• Choice of comprehensive Medical, Vision and Dental Insurance plans
• Paid vacation time and sick days
• Corporate holidays annually
• Participation in the 401K Plan
• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
• Health Advocate and Employee Assistance Program

Location

Princeton, NJ preferred; applicants based in Brazil and Argentina are also encouraged to apply.

Equal Opportunity Employer Statement

EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.