Job description - Clinical Operations Manager
Alternative job titles
Director of Clinical Operations ClinOps Manager
Director Clinical Research
Description
The Clinical Operations Managers supports development of Clinical Affairs infrastructure and program operations to ensure high quality and timeliness of clinical trials. Oversees operational aspects of all clinical studies worldwide and provides strategic direction for clinical trial operations through the direct line-management of the clinical research staff. The Clinical Operations Manager is responsible for the development and implementation of clinical research processes and systems.
Qualifications
The candidate must be in possession of a degree (bachelor, MD or PhD) in a related field and have extensive clinical research experience. He/she should have strong knowledge of GCP and local and international regulatory requirements.
Competencies
- Recognise opponents' goals and adjust own strategies to reach a result
- Ability to discuss strategic and sensitive issues
- Ability to work across all levels influencing client and organisation culture
- Shares knowledge
- Understand and develop long term business vision
- Careful delegation of tasks whilst maintaining responsibility for final result
- Inspire others to share their vision and support them to reach a common goal
Tasks
- Responsible for development and implementation of global clinical operation strategy
- Review clinical protocols, CRF's, study reports, informed consent
- Ensures consistency of and adherence to global clinical standards worldwide
- Ensures that clinical research is cost effective by analyzing internal and external costs, resource utilization and performance data
- Responsible for hiring/firing clinical research personnel
- Plan, identify resources for global clinical studies based on project timelines
- Negotiate, establish contracts with external resources
- Identify emerging trends/regulations in clinical research while proactively integrating these elements into policies and procedures
- Development of training programs for internal and external resources
- Assist, participate in other Clinical Affairs projects or clinical studies as required
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