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Central Monitoring Head

10+ years
Not Disclosed
10 Feb. 19, 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
Company: Novartis Healthcare Private Limited


About the Role:

The Central Monitoring Head is a strategic leadership role focused on advancing central monitoring capabilities in clinical trials at Novartis. This position will oversee the integration of new processes, technologies, and teams to support the latest regulatory requirements. You will build and manage a state-of-the-art central monitoring function, collaborate cross-functionally, and drive innovation within the clinical trial monitoring landscape.


Key Responsibilities:

  • Strategy & Execution:

    • Establish and implement Clinical Monitoring functions, processes, and governance frameworks.

    • Define and execute strategies using data analytics and centralized oversight.

    • Optimize resourcing strategies, including hiring, training, and team development.

    • Provide senior leadership updates on monitoring performance, challenges, and improvement opportunities.

    • Ensure the Clinical Monitoring function adapts to new regulations and continues to add value.

  • Collaboration with Stakeholders:

    • Coordinate cross-functional interactions with teams in development, data analytics, quality assurance, and regulatory affairs.

    • Act as a liaison between central monitoring, field monitoring, and global risk surveillance teams.

    • Partner with SSO Hub Heads to integrate central monitoring into the existing monitoring ecosystem.

  • Leadership & Change Management:

    • Lead the organization through the transition to a central monitoring model.

    • Champion innovation, staying ahead of industry trends and advancements.

    • Foster collaboration and eliminate silos to achieve organizational alignment and success.

  • Key Performance Indicators:

    • Successfully deploy and integrate the Central Monitoring function and platform with trial monitoring workflows.

    • Improve performance metrics, such as data completeness, protocol compliance, and audit outcomes.

    • Ensure high-quality deliverables, adherence to data quality standards, and timely issue resolution.

    • Achieve monitoring milestones within defined timelines, including Risk-Based Monitoring (RBM) targets.


Qualifications:

  • Education: University degree in life sciences, business, or operations; advanced degree preferred.

  • Experience:

    • Minimum 10 years of experience in the pharmaceutical industry, specifically in clinical research and clinical trial development.

    • At least 6 years of experience in people management and leadership, with proven success in developing high-performing global teams.

    • Strong experience in central monitoring and understanding of clinical trial monitoring processes.

    • Comprehensive knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.

    • Expertise in study operations process set-up and improvements.

  • Skills:

    • Strong leadership and team management abilities in a global setting.

    • Excellent technical, analytical, and problem-solving skills.

    • Ability to articulate strategic vision and drive collaboration across teams.


Why Novartis?

At Novartis, we work together to create a brighter future for patients. Our commitment to innovation and collaboration makes us a leading force in pharmaceutical research. Join us in our mission to improve and extend people's lives.

  • Diversity & Inclusion: Novartis fosters an inclusive and diverse work environment, reflecting the communities we serve.

  • Benefits & Rewards: Explore the benefits and rewards offered to our employees.


How to Apply

To apply, visit the Novartis Career Portal and submit your application.


Additional Information

  • Accessibility: Novartis is committed to providing reasonable accommodations during the recruitment process. If you require assistance, please contact diversityandincl.india@novartis.com.


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