Central Monitoring Head

6-10 years

Not Disclosed

Hyderabad India

10 Feb. 10, 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
Location: India (Hyderabad, Office)
Job ID: REQ-10038756
Date Posted: Feb 05, 2025
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-Time, Regular
Shift Work: No

Job Purpose

The Central Monitoring Head will lead the establishment and execution of a comprehensive Clinical Monitoring (CM) function at Novartis. This role is focused on advancing central monitoring capabilities, integrating them into existing monitoring frameworks, and ensuring compliance with new regulations. The incumbent will play a key role in driving innovation, managing operational change, and building a high-performing team.

Key Responsibilities

Strategy & Execution

Establish and implement the Clinical Monitoring function, including processes, tools, and governance frameworks.
Define and execute Clinical Monitoring strategies leveraging data analytics and centralized oversight.
Develop and optimize the CM resourcing strategy, including hiring, onboarding, team development, and retention.
Actively monitor and report on CM objectives, key metrics (KPIs), and industry benchmarks to senior leadership.
Ensure CM functions evolve to remain a value-added entity and stay compliant with the latest regulations.

Collaboration with Stakeholders

Coordinate cross-functional interactions between monitoring teams and stakeholders such as CDO, Data Analyst teams, quality assurance, and regulatory affairs.
Serve as a key liaison between the CM function, global Risk Surveillance team, and field monitoring functions.
Partner with SSO Hub Heads to integrate central monitoring within the existing monitoring ecosystem, adjusting roles as necessary.

Leadership & Change Management

Guide the transition to a CM model, driving organizational and operational changes.
Champion CM innovation by identifying opportunities for technological advancements and staying ahead of industry trends.
Break down organizational silos, promote collaboration, and foster a unified purpose across teams.

Performance Metrics

Build, deploy, and integrate CM functions and technologies, ensuring alignment with trial monitoring workflows.
Enhance monitoring performance, such as improving data completeness, protocol compliance, and reducing audit findings.
Maintain high-quality monitoring deliverables, ensuring timely issue resolution and adherence to data quality standards.
Achieve monitoring milestones within defined timelines, including risk-based monitoring targets and KPIs for centralized data surveillance.
Harmonize field and CM efforts to enhance trial oversight and reduce operational variability.

Qualifications

Training and Education

University degree in Life Sciences, Business, or Operations (Advanced degree preferred).

Experience

≥ 10 years of pharmaceutical industry experience, with expertise in clinical research, clinical trial development, risk management, and monitoring.
≥ 6 years of experience in people management and team leadership, with a proven ability to build and lead high-performing, diverse teams.
Expertise in international drug development processes, GCP/ICH standards, health authority regulations, and Novartis standards.
Strong capability in navigating a Global/Country matrixed environment and working cross-functionally.
Proven track record in improving or setting up study operations processes.

Technical Competencies

Strong technical, analytical, and quantitative problem-solving skills.
Ability to understand and articulate the bigger picture, fostering trust and confidence within teams.
Fluency in English is required.

Additional Information

Why Novartis: At Novartis, we are committed to achieving breakthroughs that change patients' lives. Join us and be part of a community of passionate, smart people collaborating to make a difference.
Commitment to Diversity & Inclusion: Novartis is committed to creating an inclusive work environment and building a diverse team representative of the patients and communities we serve.

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