Clinical Trial Manager job description
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What does a Clinical Trial Manager do?
The Clinical Trial Manager is critical in overseeing the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards. This role is pivotal for advancing research goals and enabling timely, effective trial completions that support drug development initiatives.
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What are the Key Responsibilities of Clinical Trial Manager
- Plan and coordinate clinical trials following regulatory guidelines.
- Supervise and lead clinical operations teams.
- Ensure data integrity and compliance with trial protocols.
- Communicate trial progress and issues to stakeholders.
- Manage trial budgets and timelines effectively.
- Oversee site selection and monitor site performance.
- Implement risk management strategies for trials.
- Develop and update trial documentation as required.
What are the Skills and Requirements for a Clinical Trial Manager?
- In-depth knowledge of clinical research processes and regulatory requirements.
- Strong project management and organizational skills.
- Effective leadership and team coordination abilities.
- Excellent communication and stakeholder management skills.
- Proficient in clinical trial management software.
What are the KPIs to track for Clinical Trial Manager?
The Clinical Trial Manager's performance is evaluated based on the successful execution of trial protocols, adherence to timelines and budgets, and the ability to handle regulatory compliance and quality assurance issues effectively.
Trial Execution
Timely and successful completion of trials according to protocol.
Budget Management
Adherence to trial budgets without significant variances.
Regulatory Compliance
Minimal compliance issues with regulatory bodies.
Reports to
Director of Clinical Operations
Collaborates with
Regulatory Affairs Teams, Medical Affairs Teams
Leads
Clinical Research Associates, Clinical Project Coordinators
Are any specific tools or software required for the Clinical Trial Manager role?
- Medidata Rave
- Oracle Clinical
- Veeva Systems
- MS Project
What is the qualification of Clinical Trial Manager?
Bachelor's degree in Life Sciences or related field, with extensive experience in clinical research management, typically 5-7 years.
