Clinical Trial Manager

Summary: 

The Clinical Trial Manager is responsible for overseeing and managing all aspects of clinical trials, while playing a critical role in the planning, execution, and successful completion of clinical studies, ensuring compliance with applicable regulations, protocols, and timelines. 

Responsibilities: 

• Collaborate with other teams to develop clinical trial protocols and study designs. 
• Define study objectives, endpoints, and patient eligibility criteria. 
• Create and review essential study documents, such as informed consent forms, case report forms, and study manuals. 
• Manage the operational aspects of clinical trials, including site selection, initiation, and monitoring. 
• Coordinate and oversee the activities of clinical research associates (CRAs), data managers, and other study personnel. 
• Ensure that study sites are properly trained on study protocols, procedures, and data collection. 
• Monitor and evaluate trial progress, including patient enrollment, data quality, and site compliance. 
• Prepare and submit necessary regulatory documents and filings, such as investigational new drug (IND) applications and ethics committee submissions. 
• Select, contract, and manage relationships with external vendors, such as contract research organizations (CROs), central laboratories, and clinical trial suppliers. 
• Coordinate data management activities, including data collection, monitoring, and cleaning. 
• Collaborate with biostatisticians and data managers to ensure accurate and timely data analysis and reporting. 
• Identify opportunities for process improvement and efficiency in clinical trial operations. 

Qualifications: 

• Bachelor's degree in Life Sciences or Healthcare-related field. 
• Experience in clinical trial management or a related role. 
• Proficient knowledge of clinical trial regulations, guidelines, and best practices. 
• Strong project management and organizational skills. 
• Excellent communication, leadership, and interpersonal skills. 
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems. 
• Detail-oriented with strong problem-solving and decision-making abilities.