摘要
About the Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.