The Senior Clinical Trial Manager (Sr. CTM) is a key member of Clinical Operations and will closely partner with the Clinical Program Manager and the EMEA Clinical Trial Manager in the oversight and conduct of the EMEA region. Assists Clinical Program Manager with set-up of regional CRO and other vendors. Oversees and assists the EMEA CTM with the following: day-to-day contact with counterpart at CRO and/or trial site. Leads EMEA regional regulatory submission strategies.
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.
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.
This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences, and includes aligning DSS study teams with program- and study-level strategies. For assigned programs and studies, the role leads the DSS Study Team and represents DS as a member of the cross-functional study team. The role also utilizes operational analytics and project management tools to optimize execution of programs and studies.