Transcend Therapeutics

Clinical Operations

• Support the Clinical Trial Manager with planning and strategy for implementation and execution of assigned clinical trials from study startup through close-out
• Oversee day-to-day operations of assigned clinical trials including team interactions with study sites and vendors and act as an escalation point for key issues
• Identify, prepare, and implement departmental process improvement initiatives to improve operational efficiencies
• Provide expertise for drafting, finalization and implementation of clinical documents (ie, Protocol, Clinical Monitoring Plan)
• Oversee various activities and cross-functional collaboration of assigned clinical trials (e.g., monitoring, data management, drug supply logistics, labs, recruitment)
• Manage direct report(s) by providing leadership, vision and mentoring
• Proactively identify clinical data trends and escalate as needed
• Ensure Trial Master File (TMF) maintains regulatory compliance
• Support creation, review, and revision of clinical SOPs
• Ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget
• All other duties as required

Associate Director, Clinical Operations