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Clinical Data Analyst Ii

2+ years
Not Disclosed
10 Sept. 25, 2024
Job Description
Job Type: Full Time 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

Join Us at Parexel!

When our values align, there's no limit to what we can achieve. At Parexel, we share a common goal: to improve the world's health. From clinical trials to regulatory consulting and market access, our commitment to this mission drives everything we do.

Position: Clinical Data Analyst II

As a Clinical Data Analyst II (CDA II), you will lead clinical data validation activities on assigned projects, working with minimal supervision. Your responsibilities will include supporting data validation efforts, managing Data Management documents, and ensuring data integrity through various cleaning matrices.

Key Responsibilities:

  • Data Validation: Oversee data validation activities during the study conduct and database lock, including query management and reconciliation of external vendor data.
  • Data Management Documentation: Set up and maintain Data Management documents in accordance with SOPs and ICH/GCP guidelines.
  • Study Start-Up and User Acceptance Testing (UAT): Conduct user acceptance testing on clinical database setups and review protocols and EDC entry screens.
  • Project Quality Management: Ensure compliance with corporate quality standards and perform functional QC activities as needed.
  • Training and Mentorship: Maintain training compliance, provide on-the-job training, and act as a mentor for junior team members.

Skills Required:

  • Strong problem-solving and analytical skills.
  • Attention to detail and commitment to quality.
  • Effective time management and prioritization abilities.
  • Excellent interpersonal, oral, and written communication skills.
  • Ability to adapt quickly to changing environments and technologies.
  • Team-oriented mindset with collaborative work ethic.
  • Fluency in written and oral English.

Knowledge and Experience:

  • Proficient in Microsoft Office and familiar with Clinical Data Management Systems (e.g., InForm, Rave, Veeva).
  • Understanding of data management processes, ICH-GCP guidelines, and relevant local regulatory requirements.
  • Experience in clinical research and knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
  • Basic knowledge of SAS and CDISC data standards.

Education:

  • Bachelor’s degree in a related field or relevant industry experience.

Location: Office-based in Bengaluru or Hyderabad.

Join us at Parexel and contribute to the development of therapies that make a difference in patients' lives!