Site Monitoring Lead

Job Description :

Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.

We are seeking an experienced Clinical Trial Monitoring Specialist to join our team. In this role, you will be accountable for the execution of monitoring plans and ensuring the overall quality of monitoring performed by Clinical Research Associates (CRAs) for assigned US-conducted trials. You will work across a range of therapeutic areas and study phases, depending on the complexity, size, and stage of each trial.

As a key member of the Trial Team, you will be responsible for monitoring clinical trial progress, conducting site visits, and ensuring adherence to regulatory requirements. This is an exciting opportunity to lead training initiatives, manage risk-based monitoring strategies, and collaborate with internal and external stakeholders to support the success of clinical trials.

Key Responsibilities :

Trial Preparation :

• Accountable for executing monitoring plans and overseeing the quality of monitoring for assigned US trials across various therapeutic areas.
• Conduct on-site visits to assess CRA performance, including co-monitoring / supervisory visits, as needed, and provide oversight for CRAs working on assigned trials.
• Implement the monitoring plan as part of the Trial Team and monitor clinical deliverables using clinical operations systems (e.g., BI CTMS).
• Deliver and facilitate risk-based site monitoring approaches, including providing local training for the trial team.
• Develop and provide training for local trial teams, including Clinical Trial Managers (CTM) and Clinical Research Associates (CRA).
• Lead preparation for US site regulatory inspections and assist with in-house site monitoring inspection readiness activities.
• Serve as a local expert and consultant on site management and monitoring topics.
• Participate in global / regional / local Trial Team meetings and Investigator Meetings.
• Respond promptly to site management and monitoring questions from internal and external stakeholders, including Regulatory Authorities and Ethics Committees.

Trial Conduct :

Skills & Experience :

Education :

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