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Clinical Data Analyst Iii

1+ 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 III

As a Clinical Data Analyst III, you will independently perform all clinical data validation activities on assigned projects, leveraging your experience and expertise. Your responsibilities will include providing technical guidance on data validation activities and managing Data Management documents and cleaning matrices, ensuring compliance with corporate quality standards and regulatory requirements.

Key Responsibilities:

  • Data Validation: Lead and oversee data validation activities during study conduct and database lock, including query management and reconciliation of external vendor data. Highlight risks and support mitigation efforts as part of the Risk Management Plan.

  • Data Management Documentation: Set up and maintain Data Management documents according to Standard Operating Procedures and ICH/GCP guidelines.

  • Study Start-Up and User Acceptance Testing (UAT): Conduct user acceptance testing on clinical database setups, review protocols and EDC entry screens, and provide input on data management timelines.

  • Data Tracking and Entry: Track and review CRFs, and support data entry as needed.

  • Quality Management & Compliance: Ensure adherence to Standard Operating Procedures and ICH/GCP guidelines. Perform and lead quality control activities on databases and patient data.

  • Training & Mentorship: Maintain training compliance, provide on-the-job training, and mentor junior clinical data analysts. Act as a subject matter expert on data management processes and tools.

  • Process Improvement: Develop and implement project-specific tools and processes that enhance operational efficiency.

  • Project Finance & Resource Support: Analyze operations-related project variances and provide input for scope changes based on data management metrics.

Skills Required:

  • Strong leadership and collaboration skills, with the ability to coordinate tasks for the data management team.
  • Excellent negotiation skills and the ability to influence stakeholders for mutually beneficial outcomes.
  • Strong problem-solving abilities, including root cause analysis and decision-making in ambiguous situations.
  • Attention to detail and commitment to first-time quality.
  • Effective time management and prioritization skills to meet project deadlines.
  • Strong interpersonal and communication skills, with the ability to present information clearly and diplomatically.
  • A flexible and adaptable attitude toward new learning and changing environments.
  • Proven accountability in meeting key responsibilities.

Knowledge and Experience:

  • Experience in the CRO industry is desirable.
  • Familiarity with clinical data management processes and regulatory requirements.
  • Strong understanding of data validation workflows and tools.
  • Written and oral fluency in English.

Education:

  • Bachelor’s degree or other relevant medical qualifications, along with pertinent industry experience.

Location: Office-based in Bengaluru or Hyderabad.

Join us at Parexel and help shape the future of patient care!