Senior Clinical Team Manager

The Senior Clinical Team Manager will oversee all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP. Responsibilities include potentially assuming Lead CTM or CSM roles, developing clinical tools such as Monitoring Plans, and contributing to the Master Action Plan. The role involves ensuring the timely setup, organization, content, and quality of the Trial Master File, and may include participation in the design of CRFs and other protocol-specific documents. Collaboration with project managers for client meetings, communication with study sites, and management of clinical activity timelines, metrics, and resource allocation are key duties. The position requires continuous monitoring of clinical trials, review of monitoring visit reports, management of CRF collection and query resolution, and potentially conducting Accompanied Field Visits and managing project financials. The role also involves ensuring timely regulatory submissions and addressing questions from ethics committees, as well as providing input into forecast estimates for clinical activities.