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.

Key Responsibilities:

• 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