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Clinical Data Analyst I

0-2 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 I

Job Title: Clinical Data Analyst I

Experience Level: 0-2 Years


Job Summary

The Clinical Data Analyst I is responsible for supporting the collection, management, and analysis of clinical data to ensure its accuracy, integrity, and compliance with regulatory requirements. This role involves working with clinical research teams, statisticians, and database managers to process and interpret clinical trial data.

As an entry-level position, the Clinical Data Analyst I will receive training and mentorship to develop skills in data validation, statistical analysis, and reporting within a clinical research environment.


Key Responsibilities

Data Collection & Management

  • Assist in the collection, entry, and validation of clinical trial data to ensure completeness and accuracy.
  • Work with Electronic Data Capture (EDC) systems and databases to maintain clinical datasets.
  • Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.

Data Analysis & Reporting

  • Perform data cleaning, validation, and reconciliation to identify discrepancies or inconsistencies.
  • Support statistical analysis and visualization of clinical trial data for reporting purposes.
  • Assist in generating clinical study reports, summaries, and presentations for stakeholders.

Collaboration & Compliance

  • Work closely with clinical research teams, biostatisticians, and database administrators to support study objectives.
  • Ensure compliance with FDA, ICH-GCP, and other regulatory standards for clinical data integrity.
  • Participate in quality assurance (QA) checks and contribute to audit preparation.

Qualifications & Requirements

Education:

  • Bachelor’s degree in Life Sciences, Biostatistics, Public Health, Computer Science, or a related field required.
  • Master’s degree in Biostatistics, Data Science, or Clinical Research is a plus.

Experience:

  • 0-2 years of experience in clinical data management, biostatistics, or a related field.
  • Internship or research experience in clinical trials, healthcare analytics, or pharmaceutical research is beneficial.

Technical Skills:

  • Familiarity with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
  • Basic understanding of statistical analysis software (e.g., SAS, R, SPSS, or Python).
  • Proficiency in Microsoft Excel, SQL, and database management tools.

Soft Skills:

  • Strong analytical and problem-solving skills with attention to detail.
  • Effective communication and teamwork skills.
  • Ability to manage multiple tasks in a fast-paced clinical research environment.

Preferred Qualifications

  • Knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards (SDTM, ADaM).
  • Experience with data visualization tools (e.g., Tableau, Power BI).
  • Understanding of regulatory guidelines such as FDA, EMA, and ICH-GCP.

Benefits & Growth Opportunities

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

How to Apply

Interested candidates should submit their resume and cover letter via email- Rush your CVs to : careers@clinztech.com