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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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