About us The Clinical Trial Manager (CTM) is responsible for supporting the planning, set-up, conduct and close-out of one or more assigned clinical trials within CatalYm’s clinical development team. The CTM works closely with internal team members (including Sr. CTMs and CTAs), external vendors, collaboration partners and clinical trial personnel to ensure successful trial execution. The CTM is part of the Clinical Sub-team and reports to the Director Clinical Operations responsible for the respective program. Clinical Trial Manager (CTM) (f/m/d) Festanstellung, Vollzeit · CatalYm GmbH Developing and implementing strategies for the assigned clinical trials Overseeing the set- up and conduct of clinical trials to ensure compliance with the clinical trial protocol and overall clinical objectives and inspection readiness Leading and managing the trial team, including monitoring the performance of clinical Sites and Service Providers Contributing to the selection and negotiations/contracting with Service Providers Preparing and managing budgets for the assigned clinical studies Ensuring data quality and integrity through regular review and evaluation of all clinical data Preparing and presenting regular updates and reports to senior management and stakeholders Selecting, and managing relationships with Investigators /clinical team at sites in close cooperation with the Medical Lead Managing the development and review of trial-related documentation including case report forms, functional plans, manuals, charters, and patient information / informed consent forms Ensuring all (serious) adverse events are reported appropriately and in a timely manner Collaborating with various departments and Service Providers to ensure trials are completed on time and within budget Organizing activities and stakeholders in context of database closure, interim and final analysis and reporting Overseeing the topicality, completeness and correctness of the Trial Master File Overseeing the closure of the assigned clinical trials including final budget reconciliation and archiving 3-5 years proven work experience as a Clinical Trial Manager Excellent understanding of Good Clinical Practice (GCP) guidelines Knowledge of clinical trial regulations, guidelines and ethical standards to ensure compliance at all stages of the trials Knowledge of data management, statistical and reporting principles in clinical trials Excellent organization and planning skills to manage all aspects of a clinical trial, from the design stage to the final report writing, and archiving Ability to multitask and manage multiple contributors/stakeholders at the same time Strong leadership and team management skills to coordinate multidisciplinary teams and ensure that all team members are on the same page Attention to details and analytical thinking to ensure accurate data collection, interpretation and reporting Problem-solving skills to address any issues or complications that may arise during all stages of the trials Excellent interpersonal and communication skills At least BSc degree or comparable education in Life Science or related field. Creative working in X-funtionals teams Short communication channels Dynamic and goal-oriented envirorment Open and appreciative corporate culture in a multicultural envirorment Flexible working hours office (min. 60%)