Global Site Monitoring Lead
Ridgefield, CT US
- Plan trial quality and risk monitoring/ mitigation as part of the Trial Team.
- Deliver Risk-based Site Monitoring approach and training for the Accountable for the development of the operational Site Monitoring & Oversight plans.
- Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA).
- Participate in development of trial level
- Behave as expert and consultant on Site management and monitoring topics.
- Integrate patient/site level feedback to the documents ensuring design with a focus on the
- Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
- Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)
Facilitate communication and direction with CT Managers and CRO CRAs.
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Including but not limited to:
- Issue management / oversight on trial
- Pre-identification of important protocol deviations from site issues/deviations
- Continuous review, risk identification, evaluation/ analysis and communication on a trial level as
- Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level
- Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) according to plan, implement follow-up actions and escalation, as
- Contribute to preparation and implementation of amendments to the trial level documents including training material updates/retraining as needed.
- Facilitate communication and training related to site monitoring in the trial:
Participate, prepare input and (co-)lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).
- Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.
Understanding of major regulations (US FDA, EMA and PMDA).
Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics.
Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking.
Solid project management and internal/external communication skills. Education: University or comparable degree in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities Required
- PROJECT MANAGEMENT
- RISK ASSESSMENT
- CLINICAL TRIAL MONITORING
- CLINICAL SITE MONITORING
- CLINICAL MONITORING