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Senior Principal Biostatistician

7+ years
Not Disclosed
10 Feb. 13, 2025
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 Title: Central Monitoring Head
Job ID: REQ-10038756
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Company / Legal Entity: Novartis Healthcare Private Limited


Role Overview

The Central Monitoring Head will be responsible for leading and establishing the Central Monitoring (CM) function at Novartis. This involves developing processes, tools, and governance frameworks, and building a high-performing team to drive innovations in clinical trial monitoring. This leadership role focuses on leveraging data analytics, collaborating with various stakeholders, managing performance, and fostering a culture of change to align with the latest clinical trial regulations and technologies.


Key Responsibilities

Strategy & Execution:

  • Establish and implement a Clinical Monitoring function, including defining strategies, tools, and governance frameworks.
  • Develop a Clinical Monitoring resourcing strategy, focusing on hiring, onboarding, team development, and retention.
  • Oversee objectives in line with Global Clinical Operations (GCO) priorities, with regular updates to senior leadership on performance.
  • Drive the evolution of the CM function to remain value-added, ensuring compliance with the latest regulations.

Collaboration with Stakeholders:

  • Coordinate cross-functional interactions with teams in Data Analytics, Compliance, Quality Assurance, Regulatory Affairs, and other relevant departments.
  • Act as the key liaison between Central Monitoring, Global Risk Surveillance, and Field Monitoring teams.
  • Integrate CM with existing monitoring ecosystems, adjusting roles and responsibilities between central and field monitoring functions.

Leadership and Change Management:

  • Lead the transition to a CM model, driving cultural and operational change to gain buy-in and ensure sustained success.
  • Champion CM innovations and stay ahead of industry trends by identifying opportunities for advancements.
  • Break down silos within the organization, focusing on collaboration and unified goals.

Performance Indicators:

  • Successful integration of CM functions and technology platforms, improving alignment with trial monitoring workflows.
  • Improvement in monitoring metrics like data completeness, protocol compliance, and audit readiness.
  • Achievement of Risk-Based Monitoring (RBM) targets and KPIs for centralized data surveillance.
  • Harmonization of field and CM efforts, leading to enhanced oversight and operational consistency.

What You’ll Bring to the Role

Educational & Professional Requirements:

  • University degree in Life Science, Business, or Operations (Advanced degree preferred).
  • ≥ 10 years of experience in the pharmaceutical industry, with a background in clinical research (Pharmaceutical or CRO).
  • ≥ 6 years of experience in people management and team leadership within a global setting.
  • Strong understanding of clinical trial development, risk management, and international drug development standards (GCP/ICH, Novartis standards).

Key Skills & Experience:

  • Extensive experience in Central Monitoring or monitoring functions in clinical trials.
  • Proven ability to lead cross-functional teams in a global/country matrixed environment.
  • Strong knowledge of data analytics, budgeting/finance, and study operations process set-up.
  • Excellent leadership and communication skills, with a strong track record in driving change management and operational excellence.

Personal Attributes:

  • Ability to articulate the bigger picture, fostering trust and confidence across teams.
  • Strategic thinker with an innovative mindset and capability to drive process improvements.
  • Fluent in English (oral and written).

Why Novartis?

Novartis is committed to improving patients' lives through innovative science and fostering an inclusive work environment. By joining the team, you’ll be part of a community that values collaboration, innovation, and the drive for breakthroughs.

For more details on the People & Culture Strategy and Benefits & Rewards, check out their career site.


Join the Novartis Network:
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This role offers an exciting opportunity to lead and shape the Central Monitoring function, creating a lasting impact on Novartis' global clinical trials while fostering collaboration and innovation within the team.