Site Monitoring Lead

Job Description:

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:

• Oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct, ensuring adherence to ICH-GCP, regulatory requirements, SOPs, and trial protocols.
• Manage issue oversight at the country level and conduct continuous review, risk identification, and analysis at the country level as applicable.
• Maintain a risk-based site monitoring approach and provide feedback on trends that may impact the Trial Level Monitoring and/or site monitoring oversight plans.
• Conduct Site and Monitoring Oversight, including Site Monitoring Oversight Visits, according to plan and implement follow-up actions and escalation as needed.
• Contribute to the preparation and implementation of trial-level documents, including training material updates and retraining as necessary.
• Facilitate communication and training for site monitoring in collaboration with CT Managers and CRAs.
• Participate in Trial Oversight Meetings at the country level and contribute to timely responses to external and internal stakeholder queries.

Skills & Experience:

• Oncology experience preferred
• Experience in Metabolic, Dermatology, or CNS therapeutic areas is a plus
• Minimum of 5 years of experience in on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, and SOPs related to clinical trials.
• Excellent communication and leadership skills, with the ability to train and mentor cross-functional teams.
• Experience in risk-based monitoring approaches and the ability to assess and manage clinical trial risks effectively.
• Ability to handle complex tasks, prioritize responsibilities, and meet deadlines in a fast-paced environment.

Education:

• Bachelor's Degree in Health Sciences, Health Care, Nursing, or a related field.
• Minimum of 5 years of experience performing on-site monitoring or 8 years of relevant experience in the pharmaceutical/healthcare industry.

Job ID # 511030