Site Monitoring Lead
Clinical
Ridgefield, CT, US
Pay Rate Low: 86.50 | Pay Rate High: 92.50
Added - 23/12/2024
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Responsible for the execution and quality oversight of monitoring plans for assigned US-based clinical trials, ensuring compliance with regulatory standards and optimal trial execution across therapeutic areas.
Pay: Up to $85/hr
Type: Contract
Location: ridgefeild, CT
Key Responsibilities:
Trial Preparation:
Execute monitoring plans and ensure overall quality of monitoring for 5-8 US trials across different phases.
Conduct on-site visits and oversee CRAs, including co-monitoring and supervisory visits.
Implement trial monitoring plans and track deliverables via clinical operations systems (e.g., BI CTMS).
Deliver risk-based site monitoring and provide local training to trial teams.
Support inspection readiness and lead preparation for US regulatory inspections.
Trial Conduct:
Monitor and oversee site management activities conducted by CRO partners, ensuring compliance with ICH-GCP and trial protocols.
Manage risks and issues at the country level, ensuring adherence to SOPs and monitoring plans.
Perform Site and Monitoring Oversight visits and implement follow-up actions as needed.
Collaborate with Site Management Lead (SML-r) to update training materials and trial documents.
Facilitate communication and training for CT Managers and CRAs, providing re-training as necessary.
Qualifications:
Education
: Bachelor's degree in Health Sciences, Nursing, or related field.
Experience
: Minimum of 5 years in on-site monitoring or 8 years in a regulated pharmaceutical or healthcare environment.
Strong understanding of ICH-GCP, regulatory requirements, and trial protocols.
Ability to manage multiple trials and lead cross-functional teams.
Excellent communication, training, and risk management skills.
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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