Clinical Research Manager job description
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What does a Clinical Research Manager do?
The Clinical Research Manager plays a critical role in overseeing and coordinating clinical trials. This position is key to advancing medical research by ensuring compliance with regulatory standards and efficiently managing research teams and resources to produce reliable study results.
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What are the Key Responsibilities of Clinical Research Manager
- Plan and direct clinical research activities.
- Ensure adherence to regulatory requirements and guidelines.
- Manage study budgets and resources efficiently.
- Monitor the progress of clinical trials and address issues as they arise.
- Coordinate with research teams, sponsors, and regulatory bodies.
- Prepare detailed reports and documentation of trial results.
- Train and mentor junior clinical staff and researchers.
- Oversee patient recruitment and data collection processes.
What are the Skills and Requirements for a Clinical Research Manager?
- Strong knowledge of clinical trial regulations and compliance.
- Excellent project management and organizational skills.
- Proficient in clinical data management software.
- Exceptional communication and negotiation abilities.
- Ability to work collaboratively with cross-functional teams.
What are the KPIs to track for Clinical Research Manager?
The Clinical Research Manager's success is measured by the timely and budget-compliant completion of clinical trials, adherence to all regulatory standards, and the effective management of study logistics and team performance.
Trial Completion
Timely and successful completion of clinical trials.
Regulatory Compliance
Adherence to all relevant clinical research regulations and guidelines.
Budget Management
Effective management and use of allocated trial budgets.
Reports to
Director of Clinical Operations
Collaborates with
Research Teams, Regulatory Affairs Specialists
Leads
Clinical Research Coordinators, Clinical Trial Associates
Are any specific tools or software required for the Clinical Research Manager role?
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) software
- Microsoft Office Suite
- Statistical analysis software
What is the qualification of Clinical Research Manager?
Master's degree in Life Sciences, Nursing, or a related field with at least 5 years of experience in clinical research management.
