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Clinical Data Specialist

0-8 years
Not Disclosed
10 May 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary: Contributes, under appropriate supervision, to various aspects of global clinical trial(s) to achieve study objectives within predefined timelines, budget, quality/compliance, and performance standards. May lead specific components of global clinical trial(s). Acts as a core member of the Clinical Trial Team and promotes operational excellence through process enhancements and knowledge dissemination.

About the Role:

Major Accountabilities:

  1. Contributes to operational/clinical trial deliverables within the defined scope, ensuring adherence to timelines, budget, operational procedures, and quality/compliance standards.
  2. Participates in study start-up activities, including overseeing protocol development, CRF development, and Informed Consent Form development.
  3. May participate in identifying new clinical trial sites, assessing their capability, and recommending trial inclusion.
  4. Ensures proper handling of all study conduct and closeout activities, including site closeout, final drug accountability, and audit readiness of Trial Master File documentation.
  5. Responsible for educating, implementing, and ensuring compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and clinical program(s).
  6. Reports technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt and distributes marketing samples (if applicable).

Key Performance Indicators:

  1. Timely, efficient, and quality execution of assigned trials and trial-related activities within budget and compliance with quality standards.
  2. Proactive operational planning with effective contingency and risk mitigation plans.
  3. Adherence to Novartis policy, guidelines, and external regulations.

Minimum Requirements:

Work Experience:

  • Experience in Operations Management and Execution.
  • Proficiency in Project Management.
  • Knowledge of Financial Management.
  • Ability to collaborate across boundaries.

Skills:

  • Proficiency in Trial Planning and Feasibility.
  • Familiarity with Over The Counter Product Development.
  • Understanding of Post Authorization Data Safety.
  • Knowledge of Regulatory Strategy.
  • Competence in Clinical Trial Set-up, Management & Conduct.

Languages:

  • Proficiency in English.

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Division: Biomedical Research Business Unit: Pharma Research Location: Hyderabad, India Site: Hyderabad (Office) Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area: Research & Development Job Type: Full-time Employment Type: Regular Shift Work: No

Novartis is committed to fostering an exceptional, inclusive work environment and diverse teams that reflect the patients and communities we serve.