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Central Monitoring Head
Sandoz
posted 11hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Major accountabilities but not limited to:
- Strategy & Execution:
- Establish and implement a Clinical Monitoring function at Novartis, including processes, tools, and governance frameworks.
- Define and execute Clinical Monitoring strategies, leveraging data analytics and centralized oversight.
- Develop and optimize Clinical Monitoring resourcing strategy, including hiring, onboarding, development, and retention of Clinical Monitoring Team, and perform resource management in line with Development
- Establish and actively monitor objectives in line with GCO priorities, key metrics/KPIs and industry benchmarks.
- Update senior leadership on CM monitoring performance, challenges, and opportunities for improvement.
- In the long-term, ensure CM function evolves and adjusts to a remain a value-added function and to ensure compliance with latest regulations.
- Collaboration with Stakeholders:
- Coordinate cross-functional interactions between monitoring teams and key stakeholders within Development in areas such as CDO (especially with Data Analyst team to support CM s technologies), process and compliance, quality assurance, and regulatory affairs.
- Act as a key connector between CM, global Risk Surveillance team, and field monitoring functions.
- Partner with SSO Hub Heads to integrate central monitoring into existing monitoring ecosystem and adjust central and field monitoring roles accordingly.
- Leadership and Change Management:
- Guide the organization through the transition to a CM model, driving cultural and operational change to achieve buy-in and sustained success.
- Act as a champion for CM innovation, identifying opportunities for advancements and staying ahead of industry trends.
- Break down silos through an enterprise mindset. Focus on delivery through collaboration and bringing people together to work towards the same purpose across the organization.
- Key performance indicators:
- Successful build-up, deployment and integration of the CM function and technology platform, achieving alignment with trial monitoring workflows.
- Improved monitoring performance metrics, such as data completeness, protocol compliance, and reduction of critical findings in audits and inspections.
- Consistently high quality of monitoring deliverables, including adherence to data quality standards, risk identification, and timely issue resolution across trials.
- Achievement of monitoring milestones within defined timelines across the global portfolio, including risk-based monitoring (RBM) targets and KPIs for centralized data surveillance.
- Successful harmonization of field and CM efforts, leading to enhanced trial oversight and reduced operational variability
- Your Experience:
- University degree in life science, business or operations. An Advanced degree is preferred.
- 10 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs. Strong clinical and budgeting/finance experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials. Specific central monitoring / monitoring experience preferred.
- 6 years of recent experience in people management and/or team leadership. Strong leadership and people management skills in global setting and proven ability to develop high performing teams and diverse profiles including manager of manager experience
- Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.
- Strong capability in working in a Global/Country matrixed environment. Organizational awareness, including significant experience working cross functionally.
- Proven track record in study operations process set-up and/or improvement(s).
- Strong technical, analytical and quantitative problem-solving skills.
- Ability to articulate the bigger picture to foster confidence and trust.
- Fluent in Englis
Employment Type: Full Time, Permanent
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Sandoz Benefits
Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards 
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