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.

Key responsibilities:

•Drives program and trial field monitoring strategy to achieve Global, Hub and Local business objectives.

•Creates and implements. innovative practices and site engagement tactics to advance field planning, execution, patient engagement and quality in line with SSO strategies and objectives.

•Ensures trial execution is according to enrollment commitment, timelines, and budget

tracks performance through key performance indicators

drives Hub re-allocation or corrective action when needed in partnership with the SSO Hub Head Portfolio.

•Builds competitive advantages for global development trials within the Country/Cluster considering medical standard of care, competitive environment, and local business drivers.

•Accountable for Field Monitoring quality and issue resolution through timely review, approval, resolution and/or escalation of KPIs.

•In partnership with the SSO Strategy & Operations Country Head, responsible for development and delivery of a country resourcing strategy aligned with the Hub Resourcing strategy.

•Responsible for the hiring, training, development, and retention of a team of Field Monitoring staff to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials

•Performs ongoing assessment and allocation of monitoring resources to ensure balanced staff workload.

•Establishes a process for managing performance (recognition/corrective action) to ensure delivery to the established Key Performance Indicators (KPI)/ Key Quality Indicators (KQI)

•Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times

•Accountable for adequate CRA monitoring competency based on technical and capability training plans for CRA Managers, Monitoring Services Oversight Managers, and CRAs. Ensures management teams have plans for oversight of CRA work responsibilities as well as professional development.

•Responsible for managing and addressing staff performance targets per defined quality performance indicators. Budget and productivity

Essential requirements:

•A degree in scientific or health discipline required and advanced degree preferable

•Fluent in both written and spoken English

•Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials

•Experience and evidence of team leadership capabilities

•Understanding of all aspects of clinical drug development with particular emphasis on trial execution

Desirable requirements:

•Stakeholder management capabilities with demonstrated capability to problem solve and mediate complex issues.

•Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards

•Good understanding of the Risk Based Monitoring process and requirements

•Demonstrated negotiation and conflict resolution skills

•Communicate effectively with internal and external stakeholders

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Regulatory Compliance

Risk Management

Program Management

Clinical Research

Resource Management (Organizational)

People Management

Clinical Trials