Job Description Summary
The Field Monitoring Head will provide expertise/strategic guidance to associates within the
organization to execute the field monitoring strategy and will work closely and collaboratively with
other senior and functional leaders to ensure fully harmonized and integrated strategies and
operations to drive successful portfolio planning and execution. Responsible to coordinate and lead
the Country/Cluster field team, including CRAs, CRA Managers, and Monitoring Services Oversight
Managers in the areas of functional management. Ensures technical and capability training plans
are in place with the Global training organizations and sets culture for continued growth and
development of the field monitoring organization countrywide. Accountable for overall country CRA
resource management strategy as well as financial oversight, vendor management, and acts as an
escalation point for FSP issues in order to optimize FSP collaboration and partnership in the country.
Oversees CRA quality and performance indicators and ensures ICH/GCP compliance.
Job Description
Key Responsibilities
- Lead, develop, and engage the country Trial Monitoring organization, including CRAs, CRA Managers, and monitoring oversight roles.
- Define and execute the country field monitoring strategy in alignment with global, regional, and local objectives.
- Ensure high-quality and compliant monitoring delivery in accordance with ICH-GCP, applicable regulations, and Novartis standards.
- Develop and implement an effective resource strategy, including capacity planning, workload allocation, and oversight of internal and external resources.
- Monitor operational and quality performance through relevant KPIs and KQIs, taking timely corrective action and escalating significant risks when required.
- Ensure appropriate technical and capability development across the Trial Monitoring organization.
- Oversee FSP and monitoring vendor performance, addressing quality, delivery, and partnership issues.
- Build effective cross-functional partnerships to resolve operational challenges and support successful clinical trial planning and execution.
- Promote innovation, continuous improvement, ethical integrity, and a strong culture of quality.
Essential Requirements
- Degree in a scientific, medical, health-related, or other relevant discipline.
- Significant experience in clinical research, including the planning, execution, and/or monitoring of clinical trials.
- Proven experience leading and developing teams within Trial Monitoring or Clinical Operations.
- Strong knowledge of clinical trial execution, ICH-GCP, regulatory requirements, and quality standards.
- Demonstrated ability to manage resources, operational performance, risks, and competing portfolio priorities.
- Strong stakeholder management, communication, negotiation, and influencing skills.
- Ability to resolve complex operational issues and make sound, timely decisions.
- Fluency in written and spoken English.
Desirable Requirements
- Experience leading a country monitoring organization within a global or highly matrixed pharmaceutical environment.
- Experience overseeing FSPs, external monitoring providers, or strategic clinical operations vendors.
Required Skills
- Clinical Trial Monitoring
- Clinical Operations
- People Leadership
- ICH-GCP and Regulatory Compliance
- Quality and Risk Management
- Clinical Operations Resource Management
- Vendor and FSP Oversight
- Clinical Trial Performance Management
Benefits and Rewards
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Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation
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Additional Information
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Skills Desired
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Risk Management