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Clinical Data Specialist

2+ years
Not Disclosed
10 Oct. 16, 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

Job Description Summary

The role involves contributing to all aspects of global clinical trials to ensure the delivery of study outcomes within the specified schedule, budget, quality, compliance, and performance standards. You may lead specific components of clinical trials as a core member of the Clinical Trial Team, driving operational excellence through process improvements and knowledge sharing.

Job Description

Major Accountabilities:

  • Contribute to all operational and clinical trial deliverables within the scope of this role, adhering to timelines, budget, operational procedures, and quality/compliance standards.
  • Conduct and support study start-up activities, including overseeing protocol development, case report form (CRF) creation, and informed consent form development.
  • Participate in identifying potential new sites for clinical trials, analyzing their capabilities, and making recommendations for inclusion.
  • Ensure proper management of all study conduct and close-out activities, including site close-out, final drug accountability, and maintaining audit readiness of Trial Master File documentation.
  • Educate and implement compliance with standards (SOPs) and best practices for clinical operations and clinical data review within assigned trials and programs, including sharing lessons learned.
  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt, and manage the distribution of marketing samples where applicable.

Key Performance Indicators:

  • Timely, efficient, and high-quality execution of assigned trials and related activities within budget and in compliance with quality standards.
  • Proactive operational planning, including effective contingency and risk mitigation strategies.
  • Adherence to Novartis policies, guidelines, and external regulations.

Minimum Requirements

Work Experience:

  • Operations Management and Execution
  • Project Management
  • Financial Management
  • Cross-boundary Collaboration

Skills:

  • Trial Planning and Feasibility
  • Over-the-Counter Product Development
  • Post-Authorization Data Safety
  • Regulatory Strategy
  • Clinical Trial Set-up, Management, and Conduct

Languages:

  • Proficiency in English.