1.Coordinates the implementation of process controls in enhance the execution of monitoring procedures in accordance with ICH-GCP.
2.Supports continuous process improvement, harmonization, and simplification to increase quality, speed and productivity in trial execution focusing on monitoring and field monitor oversight. Works closely with other line function heads to ensure excellent execution and delivery of clinical trial results. Drives implementation of the self-check actions (e.g., KPIs) with appropriate area of focus, targeted and timely mitigation plans and actions.
3.Supports communication to assure high quality performance and coordination of actions derived from audits, inspections, Quality KPIs and other metrics. Identifies monitoring risks through the analysis of audit and inspection findings, Quality indicators, process deviations and monitoring self-checks. Follows-up on and remediates quality signals through co-monitoring and/or Trial Monitoring process.
4.Ensures inspection readiness through the coordination of preparation activities for the region (as needed by countries and in collaboration with local QA and the other roles in Monitoring Excellence) and risk assessments to reduce significantly the chance of a critical issues related to trial monitoring to exist in submissions.
5. Supports audits & inspections working closely with Trial managers.
6.Performs signal detection through the critical analysis of data from metrics, Quality KPIs, quality trends identified issues, Risk Management Systems, audits and inspections, root cause analyses from tools including: clinical trial management systems, trial databases, metrics, TMF, Quality KPIs and other risk management systems to target needs in an ongoing manner and putting in place actions to explore those signals and correct or remediate to improve the quality and effectiveness of monitoring.
7.Contributes to the development and implementation of new tools, processes and Operational Excellence initiatives from.
Reviews local regulations only when needed and contributes to the development of SOPs. Provides day-to-day support to monitors in the areas of monitoring processes and procedures, and systems. Supports Trial Monitoring organization to ensure understanding and compliance of processes via guidance, instructions and share information on accessible platform. Supports process understanding during launch and implementation of new systems.
1.University degree with significant life science experience. Advanced degree preferably in life sciences preferred.
2. Fluent in both written and spoken English.
1.A minimum of 5 years of experience in Trial Monitoring, being 3 years in the field monitoring area. 1+ years in quality role preferred.
Training experience desirable.
2. Expert on ICH-GCP, international (i.e. FDA, EMA) and clinical trials regulations.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.