Clinical Data Analyst

EDETEK; Princeton (KY); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

Paid vacation time and sick days

Corporate holidays annually

Participation in the 401K Plan

Health Advocate and Employee Assistant

Location support

Job summary

EDETEK is seeking a Clinical Data Analyst (or Clinical Informatics Analyst) to verify the validity of clinical trials and data gathered, ensuring processes and regulations are followed and analysis goals achieved with quality and efficiency. The role centers on data management across planning, execution, and regulatory submission.

The successful candidate will validate results, oversee data management, design reports, coordinate with clinical teams, and contribute to quality improvement

Qualifications

• 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, data management, biostatistics, and regulatory agencies
• Creative thinking, an eye for detail, working independently

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
• Coordinating with study management, clinical operations, data management, and biostatistics to determine areas to be analyzed
• Identifying resources, developing plans for data-related projects, and timelines
• Performing data validation, data reconciliation, and data surveillance
• Conducting training for technical and software programs

Skills

Data compilation

Data validation

Communication skills

Problem solving

Independent work

Tools

Clinical data management system

Regulatory compliance

Job description

AClinicalDataAnalyst (orClinicalInformaticsAnalyst) is a clinical research information professional responsible for verifying the validity of clinical trials and data gathered.He/she willensure 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 isaccurateand reliable throughout the clinicaltrialconduct, 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 ormodifyingthe system to serve new purposes and improveworkflow
• designing clinical and administrative reports
• reviewing, extracting, compiling, and analyzing study data for compliance, quality, and accuracy, and undertaking quality improvement initiatives
• coordinatingwith other relevant departments (e.g., study management team, clinical operations, clinical data management, and biostatistics) todeterminethe areas to be analyzed and see thatappropriate measuresare taken to ensure data analysis isuseful
• identifyingnecessary resources, developing plans for data-related projects, anddeterminingtimelines and milestones
• performing data validation, data reconciliation, and data surveillance
• conductingtraining for technical and software programs

Education and Experience Required

• Ability to compile, code, and categorizedata
• Ability to handlemultiple priorities and exploreinnovative solutions toproblems
• Strong interpersonal and communication skills
• Tacklingcomplex situations involving study management andconductteams, clinical data management, biostatisticians, and regulatory agencies.
• Creative thinking, an eye for detail, working independently.

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.