CLINICAL TRIAL MANAGER

Role Summary

The Clinical Trial Manager will support all aspects of Adicet Bio’s clinical trials, including site activation, patient recruitment, study monitoring, site and CRO/vendor management. The role requires experience in managing oncology clinical trials, a strong knowledge of clinical operations, ICH/GCP, and FDA regulatory requirements, and the ability to work cross-functionally with study sites, CROs, and other vendors.

Responsibilities

• Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a complex environment in accordance with quality and GCP standards with minimal oversight
• Lead the identification, evaluation, selection, and oversight of clinical trial sites, vendors and CROs
• Work closely with the Clinical Operations team to support all aspects of clinical studies
• Manage multiple clinical study vendors with oversight of activities
• Plan and conduct Investigator’s meetings
• Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plans
• Collaborate with cross functional team members to independently address routine study issues
• Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
• Identify issues for escalation, participate in problem solving and implementation of risk mitigation
• Participate in departmental and corporate initiatives
• Perform co-monitoring visits with CRO, on an as needed basis, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Ensuring data entry is up to date and site queries are resolved in a timely manner
• Assist with department compliance initiatives and SOP writing
• Generate and maintain reports, study trackers, internal and external presentations and study documents as needed
• Ensure close tracking of site enrollment and related metrics
• Establish and manage clinical trial master files (TMF)
• Complete other responsibilities as assigned

Qualifications

• BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
• A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
• Experience supporting studies in a fast-paced environment
• Success in working with CROs and vendors
• Excellent communication skills and ability to achieve milestones in a team environment
• Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Proficiency with Microsoft Word, Excel, PowerPoint and Project