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Parexel is currently seeking an experienced Site Monitoring Lead to join us, you be assigned to one of our key sponsors in the EMEA region.
Working as a Site Monitoring Lead you will be a key member of global Clinical Trial Team. SMLs are accountable for authoring the monitoring risk assessments and plans, ensuring sponsor oversight, trend analysis, signal detection and delivery of your assigned trials in close collaboration with the CRO partner to ensure delivery of the Client’s pipeline through accurate planning and efficient execution of Site Monitoring.
You will contribute to the overall success and delivery of your assigned clinical trials according to defined milestones and key performance indicators.
The SML is accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, sponsor obligations, ICH-GCP and applicable regulations and always ensure inspection readiness.
Some specifics about this advertised role
1. Dedicated to one client.
2. Delivers a risk-based site monitoring approach and training for the trial
3. Accountable for the development of the operational Site Monitoring & Oversight plans
4. Develops and provides appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)
5. Monitors progress and oversees 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.
6. Coordinates timely cleaning and delivery of clinical trial data with Trial Team and countries
Here are a few requirements specific to this advertised role.
7. University (e.g., bachelor’s 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
8. Demonstrated scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution.
9. Understand dimensions of trial complexity include protocol, patients, sites, countries, vendors.