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Principal Clinical Data Scientist

Novartis
0-2 years
INR ₹20 – 30 LPA
Hyderabad
10 June 16, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, 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

 

Key Responsibilities

Clinical Data Management Leadership

  • Lead data management activities for Phase I-IV clinical studies.

  • Oversee multiple studies and large clinical development projects.

  • Coordinate internal and external Data Management teams.

  • Drive project-level data management strategies and decisions.

Data Governance & Quality

  • Ensure consistent data management standards across programs.

  • Maintain high-quality clinical databases and deliverables.

  • Implement standardized documentation and processes.

  • Monitor data quality and compliance requirements.

Project & Stakeholder Management

  • Manage multiple projects simultaneously.

  • Collaborate with cross-functional teams and global stakeholders.

  • Provide strategic recommendations for study-level and project-level decisions.

Training & Process Excellence

  • Lead training initiatives and knowledge-sharing activities.

  • Develop scalable learning and training models.

  • Support process improvements and operational efficiency.

Audit & Inspection Readiness

  • Represent Data Operations during audits and inspections.

  • Lead audit preparation and response activities.

  • Ensure compliance with GCP and regulatory requirements.


Required Skills

Technical Skills

  • Clinical Data Management (CDM)

  • Data Governance

  • Data Architecture

  • Data Integration

  • Data Quality Management

  • Data Profiling

  • Clinical Database Design

  • Coding Management

  • Data Science Fundamentals

  • Master Data Management

Regulatory Knowledge

  • ICH-GCP

  • Clinical Trial Regulations

  • Regulatory Submission Support

  • Audit & Inspection Readiness

Leadership Skills

  • Team Leadership

  • Vendor Management

  • Project Management

  • Stakeholder Management

  • Cross-functional Collaboration

  • Strategic Planning


Ideal Candidate Profile

✔ 8–12+ years in Clinical Data Management

✔ Experience managing Phase I-IV clinical trials

✔ Strong understanding of:

  • Database design

  • Data validation

  • Data review listings

  • Data governance

✔ Experience handling:

  • Global studies

  • Audit inspections

  • Cross-functional teams

  • Vendor oversight

✔ Strong communication and stakeholder management skill.