Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Leads or supports cross-functional trial teams, including vendors. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
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The Principal is responsible for the delivery of service offerings and ensures the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through the delivery of superior service. This role involves leading the delivery of regulatory and quality solutions, directing and advising others in the development of work products, and executing the defined consulting scope of work.
The Clinical Trial Manager is a leadership role responsible for driving the successful execution of protocols or projects, including decentralized trials, from strategic planning through close out. This involves managing timelines, budget, SOPs, and regulatory requirements to operationalize trials across the organization and site network within Care Access Research.
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities.