Clinical Lead
CurrentDriving and managing the clinical components of the Start up process from site ID to qualification and site activation.Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safetyCreates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriatelyEnsures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issuesPlans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestonesApply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses
