Clinical Trial Manager at Abata Therapeutics

The Clinical Trial Manager will oversee the strategic implementation and execution of clinical trials from start-up to close-out, managing CROs, study vendors, and clinical trial sites. This role involves ensuring trials are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. Key duties include preparing and maintaining study files, organizing meetings, coordinating clinical trial equipment and supplies, ensuring team compliance with training, performing TMF reviews, supporting sites for audits, assisting with budget management, tracking subject and site activity, identifying and escalating issues, and contributing to study setup activities such as protocol development and regulatory submissions. The manager will also collaborate with CROs for TMF document collection, coordinate with regulatory affairs, support study close-out activities, and communicate effectively with study team members, while participating in process improvement initiatives.