Provide project management and program oversight to plan and manage clinical trials in accordance with regulations
Responsible for the high quality conduct of all DotLab clinical trials
Collaborate with advisors, PIs, statisticians, regulatory consultants, and DotLab leadership to develop robust clinical trial protocols
Facilitate all study startup activities, including identifying, qualifying, and auditing clinical trial sites and ensuring they are properly trained to comply with clinical study protocols and SOPs
Develop required clinical study documentation in accordance with regulations (e.g., to seek IRB approvals, patient consent forms)
Oversee and drive patient recruitment across study sites, including implementing recruitment programs as needed
Proactively monitor trials by arranging regular site visits, ensuring compliance, and ensuring appropriate data collection
Provide regular updates to key stakeholders regarding study progress (e.g., leadership, PIs, site staff) via formal and informal written communications and meetings
Prepare and manage study budgets, negotiate budget agreements with trial sites, and oversee trial spending
Oversee trial data management, including development of case report forms, managing EDC systems, developing data QC protocols, collecting required source documentation, and ensuring all queries have been closed prior to study completion
REQUIREMENTS
Excellent project management skills, with an ability to manage multiple priorities, timelines, resources, and stakeholders
Deep experience working with CROs
Ability to work independently
Ability to think strategically about clinical development requirements but also execute day-to-day activities