Senior CTMA Manager, Regional Clinical Study Management
New
B
BeiGeneClinical Operations
Remote (US)Full-TimeManager
Salary$136,400.00 - $181,400.00 annually
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Job Details
- Required Skills
- MS Office
Requirements
- Solid leadership and management experience, either as a direct line manager or cross-functional team lead.
- Demonstrated expertise in clinical operations and trial management practices.
- Strong understanding of ICH/GCP guidelines and local regulatory requirements.
- Proven ability to work independently and manage multiple priorities in a fast-paced environment.
- Excellent interpersonal, organizational, and influencing skills.
- Strong written and verbal communication abilities.
- Advanced proficiency in MS Office suite.
- Experience with project planning applications.
- Ability to exercise sound judgment and discretion in significant matters.
Responsibilities
- Manage and lead Clinical Trial Management Associate (CTMA) team members, including performance management, coaching, and professional development.
- Assign and allocate staff to clinical research projects based on experience and training requirements.
- Support cross-functional clinical study teams throughout the study lifecycle, from start-up through close-out.
- Contribute to the setup, maintenance, and quality of the trial master file (eTMF).
- Maintain clinical operations tools including CTMS, EDC, and IRT.
- Develop and review Clinical Operations Work Instructions and SOPs while adhering to ICH/GCP regulations.
- Drive process improvements and best practices by identifying opportunities and sharing lessons learned.
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