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Clinical Data Analyst Iii

4-6 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Data Analyst III

Job Title: Clinical Data Analyst III

Experience Level: 4-6 Years

Application Email: careers@clinztech.com


Job Summary

ClinzTech is seeking a highly skilled Clinical Data Analyst III to join our team. The successful candidate will be responsible for managing, analyzing, and interpreting complex clinical trial data to ensure accuracy, compliance, and efficiency in clinical research processes. This role requires advanced expertise in clinical data management, statistical analysis, and regulatory compliance to support clinical trials and healthcare analytics.

As a senior-level analyst, you will collaborate with cross-functional teams, provide strategic insights, and contribute to data-driven decision-making.


Key Responsibilities

Clinical Data Management & Analysis

  • Lead the collection, validation, and analysis of clinical trial data.
  • Ensure data integrity, consistency, and compliance with industry regulations (FDA, ICH-GCP, CDISC).
  • Work with Electronic Data Capture (EDC) systems to manage clinical datasets efficiently.
  • Develop and execute data validation, cleaning, and reconciliation processes to ensure data accuracy.

Statistical & Predictive Analysis

  • Perform statistical modeling and data analysis to generate insights for clinical trials.
  • Utilize SAS, R, Python, or other statistical tools to analyze clinical datasets.
  • Assist in the development of data visualization dashboards (Power BI, Tableau).

Regulatory Compliance & Reporting

  • Ensure compliance with FDA, EMA, ICH-GCP, and CDISC (SDTM, ADaM) guidelines.
  • Generate clinical study reports (CSRs), data listings, and summary tables.
  • Support audit preparation and respond to regulatory queries regarding clinical data.

Collaboration & Leadership

  • Work closely with biostatisticians, clinical research teams, and regulatory affairs.
  • Train and mentor junior analysts in clinical data analysis methodologies.
  • Contribute to process improvement initiatives for data standardization and automation.

Qualifications & Requirements

Education:

  • Bachelor’s or Master’s degree in Biostatistics, Data Science, Computer Science, Life Sciences, or a related field.

Experience:

  • 4-6 years of experience in clinical data analysis, biostatistics, or healthcare analytics.
  • Strong expertise in Electronic Data Capture (EDC) systems (Medidata Rave, Oracle Clinical).
  • Hands-on experience with statistical programming tools (SAS, R, Python).

Technical Skills:

  • Advanced proficiency in SQL, data visualization tools (Power BI, Tableau), and Excel.
  • Deep understanding of CDISC standards (SDTM, ADaM) and regulatory requirements.
  • Experience in automation of data pipelines and reporting is a plus.

Soft Skills:

  • Excellent analytical, problem-solving, and critical-thinking skills.
  • Strong communication and stakeholder management abilities.
  • Ability to work in fast-paced environments with cross-functional teams.

Preferred Qualifications

  • Experience in machine learning or AI-driven clinical data analysis.
  • Familiarity with Real-World Data (RWD) and Real-World Evidence (RWE) analytics.
  • Knowledge of clinical trial management systems (CTMS).

Benefits & Growth Opportunities

  • Competitive salary and performance-based bonuses.
  • Comprehensive health, dental, and vision insurance.
  • 401(k) retirement plan with employer match.
  • Opportunities for professional development and certifications.
  • Collaborative work environment with mentorship from industry experts.

How to Apply

Interested candidates should email their CVs to careers@clinztech.com with the subject line: Clinical Data Analyst III Application – [Your Name].

For more information about ClinzTech, visit ClinzTech.