Job description - Clinical Research Manager (CRM)
Alternative job titles
Clinical Trial Manager Clinical Scientist
Study Manager Project leader
Description
The role of the Clinical Research Manager (CRM) is to provide leadership in clinical trial activities. The CRM is responsible for managing the planning, implementation, and tracking of clinical monitoring process, administration of clinical trials, maintaining an overview of the clinical trials, and their integration into a registration package. The position requires an active role in developing the plan and monitoring of both manpower and clinical trial so that all aspects of the plan are in progress.
Qualifications
The candidate must have extensive experience as a CRA including people-management experience and the ability to interact effectively with investigators and cross-functional teams. He or she possesses medical and technical aptitude and can demonstrate comprehensive and current knowledge in relevant therapeutic or product areas. Possess an excellent command of medical and scientific areas assigned. Professional use of the English language; both written and verbal.
Competencies
- Understands clients' needs
- Make strategic decisions
- Inspire others to share their vision and support them to reach a common goal
- Coordination and planning of budgets, people and time management
- Dedicated to improving results
- Conscientious and precise delivery of work even when under pressure
Tasks
- Supervise research staff and ensure that they are reviewed regularly, remain relevant and adhered to
- Accountable for site activities including site timelines, study visits, site selection, site initiation, site management, study drug management and closeout activities
- Recommend policies, procedures and processes to ensure high level of QC and QA
- Manage ongoing communication of operation issues and provide accurate progress reports on assigned activities to study team
- Responsible for managing site and/or vendor budget activities
- Participation in protocol development, CRF design, project plans and clinical report writing
- Develops reviews and approves regulatory and other required study documents for GCP compliance
- Contributes to projects that support wider organizational goals
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